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The Premier Consulting Blog

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The eTMF: Key Considerations and Common Pitfalls for Managing Your Electronic Trial Master File
September 21, 2022

The eTMF: Key Considerations and Common Pitfalls for Managing Your Electronic Trial Master File

Mastering the Active Substance Master File (ASMF) Submission Process
September 8, 2022

Mastering the Active Substance Master File (ASMF) Submission Process

Regulatory Project Management: Streamlining Success through a Single Point of Contact
September 2, 2022

Regulatory Project Management: Streamlining Success through a Single Point of Contact

The Target Product Profile: Basics and Benefits
June 15, 2022

The Target Product Profile: Basics and Benefits

8 New Elements of the IVDR — and How to Change Your Approach
May 19, 2022

8 New Elements of the IVDR — and How to Change Your Approach

The In Vitro Diagnostic Medical Device Regulation: What You Need to Know
May 12, 2022

The In Vitro Diagnostic Medical Device Regulation: What You Need to Know

Improving NDA Approval Odds for New Dosage Forms of Approved Products
May 10, 2022

Improving NDA Approval Odds for New Dosage Forms of Approved Products

Next Step in the NHP Shortage: New FDA Guidelines
May 5, 2022

Next Step in the NHP Shortage: New FDA Guidelines

Real-World Data in Orphan and Ultra-Rare Diseases: Making the Case to the FDA
April 25, 2022

Real-World Data in Orphan and Ultra-Rare Diseases: Making the Case to the FDA

New Drug Development: Mastering the Modules of the Common Technical Document
April 8, 2022

New Drug Development: Mastering the Modules of the Common Technical Document

505(b)(1) versus 505(b)(2): They Are Not the Same
March 18, 2022

505(b)(1) versus 505(b)(2): They Are Not the Same

The Key to Streamlining Regulatory Approval for IVDs
February 15, 2022

The Key to Streamlining Regulatory Approval for IVDs

5 Tips to Avoid an IND Clinical Hold: Regulatory Guidance and Insights
February 12, 2022

5 Tips to Avoid an IND Clinical Hold: Regulatory Guidance and Insights

PDUFA VII: More Changes Coming in the Latest Reauthorization
January 12, 2022

PDUFA VII: More Changes Coming in the Latest Reauthorization

The Composition and Value of a Portfolio Analysis
December 23, 2021

The Composition and Value of a Portfolio Analysis

PDUFA VII: Implications for Developers of Cell and Gene Therapies
December 21, 2021

PDUFA VII: Implications for Developers of Cell and Gene Therapies

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis
December 14, 2021

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics
November 30, 2021

Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Equal Parts Caregiver and Advocate: Clinical Trials from the Caregiver’s Point of View
November 23, 2021

Equal Parts Caregiver and Advocate: Clinical Trials from the Caregiver’s Point of View

Using the 505(b)(2) Pathway to Streamline Approval of Combination Products
October 26, 2021

Using the 505(b)(2) Pathway to Streamline Approval of Combination Products

Regulatory Strategy for Combination Devices: Working with the FDA for Program Success
October 21, 2021

Regulatory Strategy for Combination Devices: Working with the FDA for Program Success

Advancing from Research to Development: What Can Go Wrong?
September 30, 2021

Advancing from Research to Development: What Can Go Wrong?

The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?
August 23, 2021

The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Developmental and Reproductive Toxicology (DART) Studies: How Do They Fit into Your Program?
August 18, 2021

Developmental and Reproductive Toxicology (DART) Studies: How Do They Fit into Your Program?

The State of Pediatric Clinical Research: An Interview with Paidion CEO Barry Mangum, PharmD, FCP
July 30, 2021

The State of Pediatric Clinical Research: An Interview with Paidion CEO Barry Mangum, PharmD, FCP

Gene Therapy and Pharmacokinetics
July 28, 2021

Gene Therapy and Pharmacokinetics

New FDA Draft Guidance Provides Insights on Use of PROs in Oncology Trials
July 7, 2021

New FDA Draft Guidance Provides Insights on Use of PROs in Oncology Trials

ANDA or 505(b)(2)?: Choosing the Right Abbreviated Approval Pathway for Your Drug
June 29, 2021

ANDA or 505(b)(2)?: Choosing the Right Abbreviated Approval Pathway for Your Drug

Improving the Pediatric Patient Journey with Decentralized Clinical Trials
June 24, 2021

Improving the Pediatric Patient Journey with Decentralized Clinical Trials

Niche Nonclinical Studies: Uncommon Routes of Administration and Animal Models
June 10, 2021

Niche Nonclinical Studies: Uncommon Routes of Administration and Animal Models

FDA Designations for Rare Disease Products, Part 4: Humanitarian Use Device
May 20, 2021

FDA Designations for Rare Disease Products, Part 4: Humanitarian Use Device

FDA INTERACT Meetings: Early Interactions for Cell and Gene Therapy Sponsors
May 3, 2021

FDA INTERACT Meetings: Early Interactions for Cell and Gene Therapy Sponsors

Using PK Modeling and Simulation to Plan Studies for Pediatric Patient Populations
April 29, 2021

Using PK Modeling and Simulation to Plan Studies for Pediatric Patient Populations

Development of Oncology Therapies – Tips from the FDA to Drive Success
April 21, 2021

Development of Oncology Therapies – Tips from the FDA to Drive Success

2020 505(b)(2) NDA Approvals: A Year in Review, and What a Year It Was!
April 14, 2021

2020 505(b)(2) NDA Approvals: A Year in Review, and What a Year It Was!

In the News: Regulatory and Development Updates
April 7, 2021

In the News: Regulatory and Development Updates

Key Changes in the Revised EMA Guidance on Clinical Trials During COVID
March 31, 2021

Key Changes in the Revised EMA Guidance on Clinical Trials During COVID

FDA Designations for Rare Disease Products, Part 3: Rare Pediatric Disease Designation
March 25, 2021

FDA Designations for Rare Disease Products, Part 3: Rare Pediatric Disease Designation

How to Position Your Program to Investors: Leveraging FDA Feedback to Communicate Risk and Boost Confidence
March 18, 2021

How to Position Your Program to Investors: Leveraging FDA Feedback to Communicate Risk and Boost Confidence

Advancing Patient Healthcare: Clarifying the 2019 Changes in India’s Drug and Clinical Trial Rules
March 16, 2021

Advancing Patient Healthcare: Clarifying the 2019 Changes in India’s Drug and Clinical Trial Rules

The First Step for Streamlined CMC Development: Optimize the Target Product Profile
March 11, 2021

The First Step for Streamlined CMC Development: Optimize the Target Product Profile

Technology Transfer: What Is It, and How Is It Done?
March 11, 2021

Technology Transfer: What Is It, and How Is It Done?

Top 5 Common Misconceptions About Meeting with the FDA
February 25, 2021

Top 5 Common Misconceptions About Meeting with the FDA

FDA Designations for Rare Disease Products, Part 2: Orphan Drug Designation
February 17, 2021

FDA Designations for Rare Disease Products, Part 2: Orphan Drug Designation

How PK Modeling Can Inform Sample Size Estimation and Dose Selection for Your Product
February 11, 2021

How PK Modeling Can Inform Sample Size Estimation and Dose Selection for Your Product

FDA Designations for Rare Disease Products, Part 1
January 28, 2021

FDA Designations for Rare Disease Products, Part 1

Navigating the Global NHP Shortage: How to Keep Your Nonclinical Development Program on Track
January 12, 2021

Navigating the Global NHP Shortage: How to Keep Your Nonclinical Development Program on Track

Nonclinical Pulmonary Drug Delivery: Setting Up Your Inhalation Drug Study for Success
November 25, 2020

Nonclinical Pulmonary Drug Delivery: Setting Up Your Inhalation Drug Study for Success

Juvenile Nonclinical Studies: What’s Involved, and How do I Proceed?
November 20, 2020

Juvenile Nonclinical Studies: What’s Involved, and How do I Proceed?

Don’t Underestimate the Value of a Pre-NDA Meeting
November 19, 2020

Don’t Underestimate the Value of a Pre-NDA Meeting

Anatomy of a Nonclinical Study Monitoring Report
October 29, 2020

Anatomy of a Nonclinical Study Monitoring Report

Single-Arm Trials Using Real-World Evidence for Rare Disease Product Development
October 16, 2020

Single-Arm Trials Using Real-World Evidence for Rare Disease Product Development

“Get the First Inch Right”: Oncology Combination Product First-in-class Treatment Success Story
October 9, 2020

“Get the First Inch Right”: Oncology Combination Product First-in-class Treatment Success Story

How Are Biopharma Companies Evaluating Partnerships in the Rare Disease Space?
September 24, 2020

How Are Biopharma Companies Evaluating Partnerships in the Rare Disease Space?

Prescription Digital Therapeutics: When Software Is the Active Ingredient
September 9, 2020

Prescription Digital Therapeutics: When Software Is the Active Ingredient

Accelerated Authorizations Using Surrogate Endpoints: Takeaways from DIA 2020
September 2, 2020

Accelerated Authorizations Using Surrogate Endpoints: Takeaways from DIA 2020

Developing Drug Products with the Label’s Commercial Value in Mind
August 5, 2020

Developing Drug Products with the Label’s Commercial Value in Mind

The FDA Is Ending Its Rare Pediatric Disease Priority Review Vouchers – and Time Is Running Out to Get One
July 31, 2020

The FDA Is Ending Its Rare Pediatric Disease Priority Review Vouchers – and Time Is Running Out to Get One

Preclinical and Nonclinical Studies—What Is the Difference, and Where in Your Program Should They Fall?
July 29, 2020

Preclinical and Nonclinical Studies—What Is the Difference, and Where in Your Program Should They Fall?

Multidisciplinary Team Advances Immuno-Oncology Development
July 23, 2020

Multidisciplinary Team Advances Immuno-Oncology Development

Creating a Compliant eCTD: Avoiding Common Regulatory and Technical Pitfalls on the Path to Submission
July 23, 2020

Creating a Compliant eCTD: Avoiding Common Regulatory and Technical Pitfalls on the Path to Submission

A 505(b)(2) Primer: Building the Bridge Between an Approved Drug and Your Novel Therapy
July 1, 2020

A 505(b)(2) Primer: Building the Bridge Between an Approved Drug and Your Novel Therapy

Repurposing Drugs As an Answer to the COVID-19 Crisis
June 19, 2020

Repurposing Drugs As an Answer to the COVID-19 Crisis

Patient-Centered Drug Development for Oncology Products
June 3, 2020

Patient-Centered Drug Development for Oncology Products

What to Expect from the FDA During COVID-19 Product Development
May 19, 2020

What to Expect from the FDA During COVID-19 Product Development

CARES Act Introduces OTC Administrative Order Process
May 8, 2020

CARES Act Introduces OTC Administrative Order Process

Choosing the Right Animal Model for COVID-19 Nonclinical Research
May 6, 2020

Choosing the Right Animal Model for COVID-19 Nonclinical Research

Three Keys to Preparing Effective Pre-IND Meeting Questions
April 16, 2020

Three Keys to Preparing Effective Pre-IND Meeting Questions

COVID-19 & Clinical Trials: Direct-to-Patient Model Keeps Research Moving and Patients Safe
April 7, 2020

COVID-19 & Clinical Trials: Direct-to-Patient Model Keeps Research Moving and Patients Safe

COVID-19 Stimulus Legislation Will Cost OTC Manufacturers
April 2, 2020

COVID-19 Stimulus Legislation Will Cost OTC Manufacturers

Snapshot: A New Guidance Document Program From the FDA
March 27, 2020

Snapshot: A New Guidance Document Program From the FDA

Statistical Considerations for FDA COVID-19 Guidance
March 27, 2020

Statistical Considerations for FDA COVID-19 Guidance

Emergency Use Authorizations: What Is an EUA, and Does Your Product Qualify?
March 26, 2020

Emergency Use Authorizations: What Is an EUA, and Does Your Product Qualify?

Why Did My NDA Become a BLA on March 23, 2020?
March 25, 2020

Why Did My NDA Become a BLA on March 23, 2020?

Global Health Authorities Push for Rapid Development of COVID-19 Tests, Drugs and Vaccines
March 20, 2020

Global Health Authorities Push for Rapid Development of COVID-19 Tests, Drugs and Vaccines

FDA Issues Guidance on Clinical Trials During COVID-19
March 20, 2020

FDA Issues Guidance on Clinical Trials During COVID-19

UPDATE – Draft FDA Guidance Concerning Combination Products
March 18, 2020

UPDATE – Draft FDA Guidance Concerning Combination Products

FDA Releases Draft Guidance for Transdermal Product Development
March 12, 2020

FDA Releases Draft Guidance for Transdermal Product Development

Streamline Early Clinical Development With an INTERACT Meeting
March 11, 2020

Streamline Early Clinical Development With an INTERACT Meeting

2019 505(b)(2) NDA Approvals in Review
March 3, 2020

2019 505(b)(2) NDA Approvals in Review

Changes to Pediatric Study Plan Requirements for Oncology Drug Products: Are You Prepared?
January 17, 2020

Changes to Pediatric Study Plan Requirements for Oncology Drug Products: Are You Prepared?

Drug Development for an Aging Population
December 31, 2019

Drug Development for an Aging Population

The Opportunity for Generics Companies and Value Added Medicines in the US and Europe
October 23, 2019

The Opportunity for Generics Companies and Value Added Medicines in the US and Europe

3 Key Takeaways from the 25th Annual Charles River Biotech Symposium
September 24, 2019

3 Key Takeaways from the 25th Annual Charles River Biotech Symposium

Nonclinical Development Basics: The Right Nonclinical Strategy and Study Designs
August 22, 2019

Nonclinical Development Basics: The Right Nonclinical Strategy and Study Designs

Rare and Orphan Drug Development in the EU
August 13, 2019

Rare and Orphan Drug Development in the EU

The Missing Parts of the Inactive Ingredient Database (IID)
July 12, 2019

The Missing Parts of the Inactive Ingredient Database (IID)

ANDAs Prioritized to Combat Opioid Crisis
July 9, 2019

ANDAs Prioritized to Combat Opioid Crisis

Digital Health: FDA Regulation of Mobile Medical Apps
June 27, 2019

Digital Health: FDA Regulation of Mobile Medical Apps

Is the 505(b)(2) or ANDA Pathway Right for Your Product?
May 13, 2019

Is the 505(b)(2) or ANDA Pathway Right for Your Product?

Scope of Orphan Drug Exclusivity – How Broad is Broad?
December 7, 2018

Scope of Orphan Drug Exclusivity – How Broad is Broad?

Market Assessment: Is Your Product Going To Make It On The Market?
November 8, 2018

Market Assessment: Is Your Product Going To Make It On The Market?

Break Through the Barriers: Breakthrough Therapy Designation for 505(b)(2)
October 10, 2018

Break Through the Barriers: Breakthrough Therapy Designation for 505(b)(2)

On the Fast Track: Fast Track Designation for Your 505(b)(2) Drug Development Program
September 26, 2018

On the Fast Track: Fast Track Designation for Your 505(b)(2) Drug Development Program

Are Botanical Drugs, Herbal Medicinal Supplements, and Natural Product Drugs 505(b)(2)s, Too?
September 19, 2018

Are Botanical Drugs, Herbal Medicinal Supplements, and Natural Product Drugs 505(b)(2)s, Too?

Looking for Clarification on Reporting Post-Approval Changes to a Drug Substance to the FDA? You are in Luck.
September 12, 2018

Looking for Clarification on Reporting Post-Approval Changes to a Drug Substance to the FDA? You are in Luck.

FDA Firsts and Updates: Competitive Generics, Complex Generics, SiRNA approval, and Closing the Orphan Loophole
August 23, 2018

FDA Firsts and Updates: Competitive Generics, Complex Generics, SiRNA approval, and Closing the Orphan Loophole

GDUFA I and II: Considerations for Complex Generics Innovators
August 15, 2018

GDUFA I and II: Considerations for Complex Generics Innovators

Orphan Exclusivity for ‘Same Drug’: What Has Changed Since FDARA 2017/ PDUFA VI?
August 8, 2018

Orphan Exclusivity for ‘Same Drug’: What Has Changed Since FDARA 2017/ PDUFA VI?

505(b)(2) Nonclinical Development: Examples and Advantages
August 1, 2018

505(b)(2) Nonclinical Development: Examples and Advantages

New FDA Guidance on OTC Products
July 25, 2018

New FDA Guidance on OTC Products

Complete Response Letters (CRLs): Big Trouble for Small Pharma
June 14, 2018

Complete Response Letters (CRLs): Big Trouble for Small Pharma

Getting Liposome Drug Products Approved: They Are Non-biological Complex Drugs
May 16, 2018

Getting Liposome Drug Products Approved: They Are Non-biological Complex Drugs

New FDA Guidance Illustrates Breadth of 505(b)(2) Development Programs
May 2, 2018

New FDA Guidance Illustrates Breadth of 505(b)(2) Development Programs

FDA Action on Exparel® Highlights the Importance of Letting the Data Drive the Story
April 25, 2018

FDA Action on Exparel® Highlights the Importance of Letting the Data Drive the Story

Exclusivity GAINs Additional Indications: Advantages of QIDP Designation Paired with 505(b)(2) Strategy
April 11, 2018

Exclusivity GAINs Additional Indications: Advantages of QIDP Designation Paired with 505(b)(2) Strategy

How to Get Orphan Status for 505(b)(2) Drugs
March 29, 2018

How to Get Orphan Status for 505(b)(2) Drugs

Product Ideation: Who Wants to Develop a Successful Product?
March 21, 2018

Product Ideation: Who Wants to Develop a Successful Product?

Cutting-Edge Pharmacokinetics for 505(b)(2) Programs: Can We Really Do That?
March 14, 2018

Cutting-Edge Pharmacokinetics for 505(b)(2) Programs: Can We Really Do That?

Key Questions You Must Ask Before Hiring a Drug Development Consultant
March 7, 2018

Key Questions You Must Ask Before Hiring a Drug Development Consultant

Two Investigational Applications for One Drug Product? IVD Device Requirements
February 28, 2018

Two Investigational Applications for One Drug Product? IVD Device Requirements

The Hypertension Fixed-dose Combination Product Guidance: Straight from the 505(b)(2) Playbook
February 7, 2018

The Hypertension Fixed-dose Combination Product Guidance: Straight from the 505(b)(2) Playbook

Increase the Value of your Prodrug Asset Under 505(b)(2): An Alkermes Program Update
February 1, 2018

Increase the Value of your Prodrug Asset Under 505(b)(2): An Alkermes Program Update

A 505(b)(2) Qualified Infectious Disease Product QIDP Designation – 8 Years of Exclusivity
January 10, 2018

A 505(b)(2) Qualified Infectious Disease Product QIDP Designation – 8 Years of Exclusivity

Chemistry, Manufacturing, and Controls Requirements: Bridging and 505(b)(2)
December 14, 2017

Chemistry, Manufacturing, and Controls Requirements: Bridging and 505(b)(2)

Rx-to-OTC Switch: Expanding to the US Over-the-Counter Market
December 6, 2017

Rx-to-OTC Switch: Expanding to the US Over-the-Counter Market

How Will New FDA Guidance for Generic Abuse-Deterrent Opioids Pan Out? – an Update Based on the Final Guidance
November 29, 2017

How Will New FDA Guidance for Generic Abuse-Deterrent Opioids Pan Out? – an Update Based on the Final Guidance

Complex Generics Getting Too Complicated for the Generic Approval Pathway? GDUFA II and the Pre-ANDA Program to the Rescue
November 17, 2017

Complex Generics Getting Too Complicated for the Generic Approval Pathway? GDUFA II and the Pre-ANDA Program to the Rescue

Get Your Pre-IND Meeting Done Right the First Time, and Other FDA Words of Wisdom
November 13, 2017

Get Your Pre-IND Meeting Done Right the First Time, and Other FDA Words of Wisdom

Complex Generic Drug Products: A Changing Regulatory Landscape
November 1, 2017

Complex Generic Drug Products: A Changing Regulatory Landscape

A Vitamin Approved as a Drug(!): Forget what you think you know to be true
October 25, 2017

A Vitamin Approved as a Drug(!): Forget what you think you know to be true

Gaining New Indications With Real World Data: The 505(b)(2) Sweet Spot
October 18, 2017

Gaining New Indications With Real World Data: The 505(b)(2) Sweet Spot

Drug or Device? - FDA Provides More Clarity - Or Does It?
October 11, 2017

Drug or Device? – FDA Provides More Clarity – Or Does It?

Product Selection: Which Product to Develop?
October 4, 2017

Product Selection: Which Product to Develop?

Seamless Clinical Trials: Why Didn’t We Think of That?
September 27, 2017

Seamless Clinical Trials: Why Didn’t We Think of That?

Navigating Clinical Holds
September 13, 2017

Navigating Clinical Holds

De-risking Drug Development: High-level Reasoning and Technical Methodology for Evaluating a Program’s Risk
September 6, 2017

De-risking Drug Development: High-level Reasoning and Technical Methodology for Evaluating a Program’s Risk

Optimizing Your Global Drug Development Program: Strategy for Regional Variations of the 505(b)(2) Pathway
August 30, 2017

Optimizing Your Global Drug Development Program: Strategy for Regional Variations of the 505(b)(2) Pathway

The Target Product Profile: Your Strategy to Reduce Development and Review Time
August 23, 2017

The Target Product Profile: Your Strategy to Reduce Development and Review Time

Stability Requirements in the 505(b)(2) Space: Why, What, When, How
August 17, 2017

Stability Requirements in the 505(b)(2) Space: Why, What, When, How

Totality of Evidence and 505(b)(2): Are Two Phase III Studies Too Many for a Well-Known Already-Approved Drug?
August 9, 2017

Totality of Evidence and 505(b)(2): Are Two Phase III Studies Too Many for a Well-Known Already-Approved Drug?

Deuterization: Is it Enough to Get 5- or 7-Year Exclusivity for a 505(b)(2) Product?
August 2, 2017

Deuterization: Is it Enough to Get 5- or 7-Year Exclusivity for a 505(b)(2) Product?

Recent Developments for Abuse-Deterrent Opioids: FDA and Payers Influence Societal and Market Impact
July 26, 2017

Recent Developments for Abuse-Deterrent Opioids: FDA and Payers Influence Societal and Market Impact

Pre-IND Meetings: The Increasing Frequency of Written Responses Only, and Which FDA Divisions Use Them the Most
July 12, 2017

Pre-IND Meetings: The Increasing Frequency of Written Responses Only, and Which FDA Divisions Use Them the Most

The New Reality of Generics under GDUFA
June 28, 2017

The New Reality of Generics under GDUFA

PREA Requirements for Biosimilar and Interchangeable Biological Products
June 21, 2017

PREA Requirements for Biosimilar and Interchangeable Biological Products

Brexit and EMA: The Changes Have Begun
June 7, 2017

Brexit and EMA: The Changes Have Begun

Due Diligence Assessment: Determining a Drug Product’s Potential Value
May 17, 2017

Due Diligence Assessment: Determining a Drug Product’s Potential Value

The Value of a Strategic Assessment: Aligning for Success from the Start
May 10, 2017

The Value of a Strategic Assessment: Aligning for Success from the Start

Abuse-Deterrent Opioids – The Insider’s Guide to Innovation and Exclusivity in a Changing Regulatory Landscape
April 26, 2017

Abuse-Deterrent Opioids – The Insider’s Guide to Innovation and Exclusivity in a Changing Regulatory Landscape

Special Protocol Assessment: Is It Important for Your Drug Development Program?
April 19, 2017

Special Protocol Assessment: Is It Important for Your Drug Development Program?

Getting Cannabis-related Products Approved: the 505(b)(2) 4-20 Projects
April 12, 2017

Getting Cannabis-related Products Approved: the 505(b)(2) 4-20 Projects

Shortening the Review Clock: the Latest on Priority Review Vouchers
April 5, 2017

Shortening the Review Clock: the Latest on Priority Review Vouchers

DESI Drugs: Potential Targets for Quick Approvals
March 29, 2017

DESI Drugs: Potential Targets for Quick Approvals

Fixed-Dose Combination Products – Navigating the Combination Rule
March 22, 2017

Fixed-Dose Combination Products – Navigating the Combination Rule

505(b)(2) Approval Times: The Real Scoop
March 15, 2017

505(b)(2) Approval Times: The Real Scoop

Pre-IND Meetings: How to Achieve Success for 505(b)(2)
March 8, 2017

Pre-IND Meetings: How to Achieve Success for 505(b)(2)

Demystifying Orange Book Designations: The New Referencing Approved Drug Products in ANDA Submissions Draft Guidance
February 22, 2017

Demystifying Orange Book Designations: The New Referencing Approved Drug Products in ANDA Submissions Draft Guidance

Referencing a Listed Drug for the 505(b)(2) Pathway
February 15, 2017

Referencing a Listed Drug for the 505(b)(2) Pathway

Clinical Trials With Multiple Endpoints: Pitfalls and Management
February 8, 2017

Clinical Trials With Multiple Endpoints: Pitfalls and Management

Real-World Evidence: Can it Really Be Used For Drug Approvals?
February 1, 2017

Real-World Evidence: Can it Really Be Used For Drug Approvals?

Electronic Submissions Update: End of FDA Paper Submissions Looms and What It Means
January 25, 2017

Electronic Submissions Update: End of FDA Paper Submissions Looms and What It Means

Unforced Errors: FDA Refusal to File or Receive Letters
January 18, 2017

Unforced Errors: FDA Refusal to File or Receive Letters

Improvements and Updates to the FDA Inactive Ingredient Database
January 5, 2017

Improvements and Updates to the FDA Inactive Ingredient Database

A New Indication for an Old Drug. What Could Go Wrong?
December 14, 2016

A New Indication for an Old Drug. What Could Go Wrong?

Dramatically Decrease Drug Development Costs Through Literature-Only 505(b)(2) NDA Submissions
December 5, 2016

Dramatically Decrease Drug Development Costs Through Literature-Only 505(b)(2) NDA Submissions

PRO-CTCAE: Improving Oncology Drug Development
November 16, 2016

PRO-CTCAE: Improving Oncology Drug Development

Use of Clinical Data in a 505(b)(2) New Drug Application to Delay Nonclinical Testing
November 9, 2016

Use of Clinical Data in a 505(b)(2) New Drug Application to Delay Nonclinical Testing

Expedited Approval of FDA-approved Drugs in Australia: New Market Opportunities for Drugs and Devices
November 3, 2016

Expedited Approval of FDA-approved Drugs in Australia: New Market Opportunities for Drugs and Devices

505(b)(2) Application Changes: What You Need to Know
October 27, 2016

505(b)(2) Application Changes: What You Need to Know

Extrapolation of Clinical Data for Pediatric Uses: Application for Medical Devices and Drug Products
October 18, 2016

Extrapolation of Clinical Data for Pediatric Uses: Application for Medical Devices and Drug Products

Effects on Combination Products: The Biologics Price Competition and Innovation Act of 2009
October 13, 2016

Effects on Combination Products: The Biologics Price Competition and Innovation Act of 2009

Importing Investigational Pharmaceuticals to the U.S.? Changes Are Coming
September 29, 2016

Importing Investigational Pharmaceuticals to the U.S.? Changes Are Coming

Risk Evaluation and Mitigation Strategies (REMS) Basics
September 20, 2016

Risk Evaluation and Mitigation Strategies (REMS) Basics

Effects on Exclusivity: The Biologics Price Competition and Innovation Act of 2009
September 1, 2016

Effects on Exclusivity: The Biologics Price Competition and Innovation Act of 2009

Improving Drug Development ROI in 2017
August 24, 2016

Improving Drug Development ROI in 2017

Leveraging Post-Marketing Safety Data in 505(b)(2) Drug Development Programs
August 18, 2016

Leveraging Post-Marketing Safety Data in 505(b)(2) Drug Development Programs

Orphan Drug Development: Ensuring Best Time to Market
August 15, 2016

Orphan Drug Development: Ensuring Best Time to Market

Pitfalls of Changing the Salt of a Listed Drug
August 9, 2016

Pitfalls of Changing the Salt of a Listed Drug

Don’t Let Pre-Approval Inspections and the Drug Approval Process Stall Your Application
August 4, 2016

Don’t Let Pre-Approval Inspections and the Drug Approval Process Stall Your Application

Abuse Deterrence Labeling – Generic vs 505(b)(2) Drug Development
August 2, 2016

Abuse Deterrence Labeling – Generic vs 505(b)(2) Drug Development

The EU Regulatory Environment: National vs. Central Scientific Advice in the European Union
July 28, 2016

The EU Regulatory Environment: National vs. Central Scientific Advice in the European Union

Protein Product 505(b)(2)s Face a Looming Application “Dead Zone”
July 26, 2016

Protein Product 505(b)(2)s Face a Looming Application “Dead Zone”

Back to Basics: 505(b)(2) FAQs Part 4: Regulatory Strategies - Pharmacokinetic Studies
July 20, 2016

Back to Basics: 505(b)(2) FAQs Part 4: Regulatory Strategies – Pharmacokinetic Studies

The Prodrug Benefit of Utilizing the 505(b)(2) Pathway
July 13, 2016

The Prodrug Benefit of Utilizing the 505(b)(2) Pathway

Tropical or Rare Pediatric Disease Priority Review Vouchers: Update and Use of the 505(b)(2) Pathway
July 6, 2016

Tropical or Rare Pediatric Disease Priority Review Vouchers: Update and Use of the 505(b)(2) Pathway

The New FDA Draft Guidance on Chewables
June 28, 2016

The New FDA Draft Guidance on Chewables

The GRAS Is Not Always Greener: Why GRAS Status Does Not Guarantee Excipient Safety
June 21, 2016

The GRAS Is Not Always Greener: Why GRAS Status Does Not Guarantee Excipient Safety

Back to Basics: 505(b)(2) FAQs Part 3: Regulatory Strategies
June 14, 2016

Back to Basics: 505(b)(2) FAQs Part 3: Regulatory Strategies

Key Inflection Point in a Drug’s Time to Market: Choice of Regulatory Pathway
June 6, 2016

Key Inflection Point in a Drug’s Time to Market: Choice of Regulatory Pathway

Back to Basics: 505(b)(2) FAQs Part 2: Clinical and Nonclinical Studies
May 31, 2016

Back to Basics: 505(b)(2) FAQs Part 2: Clinical and Nonclinical Studies

Back to Basics: 505(b)(2) FAQs Part 1
May 16, 2016

Back to Basics: 505(b)(2) FAQs Part 1

The Regulation of Follow-On Biological Products via 505(b)(2)
May 4, 2016

The Regulation of Follow-On Biological Products via 505(b)(2)

Statistical Bootstrapping Method Using a Bias-Corrected Acceleration Approach : Take the Uncertainty out of Drug Development
April 27, 2016

Statistical Bootstrapping Method Using a Bias-Corrected Acceleration Approach : Take the Uncertainty out of Drug Development

Fixed-Combination Drug Products: Are Phase 2 and 3 Studies Really Necessary?
April 20, 2016

Fixed-Combination Drug Products: Are Phase 2 and 3 Studies Really Necessary?

Faster Approval of Combination Drug Products Via the 505(b)(2) Pathway
April 14, 2016

Faster Approval of Combination Drug Products Via the 505(b)(2) Pathway

Product Ideation: Identifying Your Optimal Drug Development Candidate
April 6, 2016

Product Ideation: Identifying Your Optimal Drug Development Candidate

Pediatric Applicability or Not--This Revised Guidance Is for You
March 23, 2016

Pediatric Applicability or Not–This Revised Guidance Is for You

Is a Reference Listed Drug Mandatory in the 505(b)(2) Pathway?
March 21, 2016

Is a Reference Listed Drug Mandatory in the 505(b)(2) Pathway?

Additional 505(b)(2) Benefits: Selective Safety Data Collection
March 14, 2016

Additional 505(b)(2) Benefits: Selective Safety Data Collection

How Much Is a First Cycle Review ANDA Approval Worth to You?
March 7, 2016

How Much Is a First Cycle Review ANDA Approval Worth to You?

Return on Investment for 505(b)(2) Products: Is an “AB” Rating Possible?
February 17, 2016

Return on Investment for 505(b)(2) Products: Is an “AB” Rating Possible?

3-Year Exclusivity May Not Be Worth as Much as You Think
January 27, 2016

3-Year Exclusivity May Not Be Worth as Much as You Think

Drug Development Question? Here's how to communicate with the FDA!
January 24, 2016

Drug Development Question? Here’s how to communicate with the FDA!

New Nonclinical Guidance for 505(b)(2) Products: No Cause for Alarm
December 15, 2015

New Nonclinical Guidance for 505(b)(2) Products: No Cause for Alarm

Enforcement Activities: FDA removes unapproved prescription ear drops
September 13, 2015

Enforcement Activities: FDA removes unapproved prescription ear drops

Examining the Amarin VASCEPA Saga
August 25, 2015

Examining the Amarin VASCEPA Saga

21st Century Cures Act - Provisions Impacting Pharmaceutical Regulation
August 13, 2015

21st Century Cures Act – Provisions Impacting Pharmaceutical Regulation

A Review of the Regulatory History of Azelaic Acid and the Changing Requirements at FDA
August 10, 2015

A Review of the Regulatory History of Azelaic Acid and the Changing Requirements at FDA

Quality Metrics - Coming Soon to Your Manufacturing Facility
July 31, 2015

Quality Metrics – Coming Soon to Your Manufacturing Facility

Final Rule - Drug Shortage Regulation: Incentive for Development of “Unapproved” Drugs?
July 20, 2015

Final Rule – Drug Shortage Regulation: Incentive for Development of “Unapproved” Drugs?

Active Ingredients vs. Active Moieties – Perplexity of Understanding the Relationship or Distinction
June 14, 2015

Active Ingredients vs. Active Moieties – Perplexity of Understanding the Relationship or Distinction

To List or Not to List – That is the Question
June 11, 2015

To List or Not to List – That is the Question

Pediatrics - What are the appropriate age ranges?
June 2, 2015

Pediatrics – What are the appropriate age ranges?

The 505(b)(2) Approval Pathway Provides Opportunities for Generics Companies Seeking New Revenue Streams
April 7, 2015

The 505(b)(2) Approval Pathway Provides Opportunities for Generics Companies Seeking New Revenue Streams

Priority Review Vouchers are a Big Carrot for Hungry Companies
March 30, 2015

Priority Review Vouchers are a Big Carrot for Hungry Companies

Opportunities in Orphan Drug Development for Investors, Pharma, and CROs
March 24, 2015

Opportunities in Orphan Drug Development for Investors, Pharma, and CROs

REMS/ETASU and Safe Use in Bioequivalence trials
March 11, 2015

REMS/ETASU and Safe Use in Bioequivalence trials

MAPPing out the timing of a Complete Response submission
February 27, 2015

MAPPing out the timing of a Complete Response submission

Extending Exclusivity: How Long Will It Really Last?
February 25, 2015

Extending Exclusivity: How Long Will It Really Last?

The Potential Unveiling or Unraveling of Dormant Therapies - 15-Year Data Exclusivity for Drugs for Unmet Needs
December 18, 2014

The Potential Unveiling or Unraveling of Dormant Therapies – 15-Year Data Exclusivity for Drugs for Unmet Needs

Manufacturing Support for “Breakthrough Therapy
December 10, 2014

Manufacturing Support for “Breakthrough Therapy” Designation for Solid Oral Dosage Forms

Therapeutic Equivalence Ratings Under 505(b)(2)
December 10, 2014

Therapeutic Equivalence Ratings Under 505(b)(2)

Orphan Drug Exclusivity for a Previously Approved Drug: a 505(b)(2) Conundrum
November 24, 2014

Orphan Drug Exclusivity for a Previously Approved Drug: a 505(b)(2) Conundrum

5-Year Exclusivity for Certain Fixed-Combination Drugs with an NCE
October 28, 2014

5-Year Exclusivity for Certain Fixed-Combination Drugs with an NCE

Alkermes Prodrug for Treatment of Multiple Sclerosis: NCE?
September 26, 2014

Alkermes Prodrug for Treatment of Multiple Sclerosis: NCE?

Paper Submissions: Going, going…away
September 22, 2014

Paper Submissions: Going, going…away

Importing pre-launch products with a bit of PLAIR
June 30, 2014

Importing pre-launch products with a bit of PLAIR

The Road to Commercial Success - The Target Product Profile
April 8, 2014

The Road to Commercial Success – The Target Product Profile

505(b)(2) Can Reference Any Scientifically Reliable Evidence - FDA's Dr. Woodcock
September 29, 2013

505(b)(2) Can Reference Any Scientifically Reliable Evidence – FDA’s Dr. Woodcock

ANDA but No NDA - What to Rely on?
July 30, 2013

ANDA but No NDA – What to Rely on?

PREA - Pediatric Plan Timing Changed by PDUFA V
July 26, 2013

PREA – Pediatric Plan Timing Changed by PDUFA V

Nonclinical Bridging: Most 505(b)(2) Programs Don't Require Full Tox Package
April 18, 2013

Nonclinical Bridging: Most 505(b)(2) Programs Don’t Require Full Tox Package

New PDUFA V Meeting Timelines
April 10, 2013

New PDUFA V Meeting Timelines

Are 505(b)(2)s
March 25, 2013

Are 505(b)(2)s “Super Generics,” or what do we call them?

No 5-Year Exclusivity for Combinations Drugs with an NCE
February 11, 2013

No 5-Year Exclusivity for Combinations Drugs with an NCE

Off-label promotion: Free Speech?
December 10, 2012

Off-label promotion: Free Speech?

Orphan Designation without Exclusivity: Court asked to decide
September 26, 2012

Orphan Designation without Exclusivity: Court asked to decide

New Generic Stability Requirements
September 25, 2012

New Generic Stability Requirements

Supreme Court upholds counterclaim provision for overbroad Orange Book Use Codes entries in ANDA patent infringement suits
April 20, 2012

Supreme Court upholds counterclaim provision for overbroad Orange Book Use Codes entries in ANDA patent infringement suits

ViroPharma Denied Request for 3-year Exclusivity
April 19, 2012

ViroPharma Denied Request for 3-year Exclusivity

Drug Development Planned Like the Titanic
April 15, 2012

Drug Development Planned Like the Titanic

Generic vs. 505(b)(2) Failure-to-Warn Liability
April 2, 2012

Generic vs. 505(b)(2) Failure-to-Warn Liability

Role of In Vitro / In Vivo Metabolism Studies in 505(b)(2) Drug Development of Metabolite Products
June 8, 2011

Role of In Vitro / In Vivo Metabolism Studies in 505(b)(2) Drug Development of Metabolite Products

Revised Safety Reporting for BE/BA Studies Effective March 28, 2011
March 23, 2011

Revised Safety Reporting for BE/BA Studies Effective March 28, 2011

What is the Pediatric Drug Development Approach for Rare Diseases and Orphan Drugs?
March 23, 2011

What is the Pediatric Drug Development Approach for Rare Diseases and Orphan Drugs?

User Fee Waivers: What is an Affiliate? New Guidance Issued
March 10, 2011

User Fee Waivers: What is an Affiliate? New Guidance Issued

Use of PK Modeling & Steady-State Simulations in 505(b)(2) Drug Development
December 13, 2010

Use of PK Modeling & Steady-State Simulations in 505(b)(2) Drug Development

When is an IND required?
October 15, 2010

When is an IND required?

Why have a Quality Overall Summary for the Quality Module?
October 5, 2010

Why have a Quality Overall Summary for the Quality Module?

Labeling for Abuse-Deterrent Drugs
June 10, 2010

Labeling for Abuse-Deterrent Drugs

Target Product Profile
May 14, 2010

Target Product Profile

505(b)(2): Repositioning, Repurposing or What?
April 20, 2010

505(b)(2): Repositioning, Repurposing or What?

FDA's Determination of Vyvanse as NME Upheld
March 12, 2010

FDA’s Determination of Vyvanse as NME Upheld

Can and Should ANDA Labeling Differ from the RLD?
February 11, 2010

Can and Should ANDA Labeling Differ from the RLD?

Pediatric Assessments in Drug Development: Timing in Europe vs. US
February 5, 2010

Pediatric Assessments in Drug Development: Timing in Europe vs. US

Analytical Requirements for Oral Solutions
January 7, 2010

Analytical Requirements for Oral Solutions

505(b)(2) Approval Standards - Referenced Studies
December 22, 2009

505(b)(2) Approval Standards – Referenced Studies

Authorized Generics Q&As
December 21, 2009

Authorized Generics Q&As

Does Europe Have a Pathway for Approval of Drugs Analogous to the FDA's 505(b)2 Pathway?
November 4, 2009

Does Europe Have a Pathway for Approval of Drugs Analogous to the FDA’s 505(b)2 Pathway?

Reference Listed Drugs (RLDs): Can More Than One Be Used?
October 30, 2009

Reference Listed Drugs (RLDs): Can More Than One Be Used?

REMS or RiskMAP or what?
October 29, 2009

REMS or RiskMAP or what?

Is There a Market For Your Drug?
October 19, 2009

Is There a Market For Your Drug?

Biosimilars: An Introduction
September 30, 2009

Biosimilars: An Introduction

Comparability Protocols
September 10, 2009

Comparability Protocols

DESI Products: Q&A
September 8, 2009

DESI Products: Q&A

Test Specifications for Stability Studies
September 1, 2009

Test Specifications for Stability Studies

Make the Most of Your Interactions with the FDA: FDA Meeting Requests
June 29, 2009

Make the Most of Your Interactions with the FDA: FDA Meeting Requests

Linking Preclinical (Safety), Clinical (Efficacy) and CMC (Quality) Development Activities
June 26, 2009

Linking Preclinical (Safety), Clinical (Efficacy) and CMC (Quality) Development Activities

ANDA Suitability Petition vs 505(b)(2)
June 12, 2009

ANDA Suitability Petition vs 505(b)(2)

Risk Evaluation Mitigation Strategy (REMS) for long-acting opioids
June 4, 2009

Risk Evaluation Mitigation Strategy (REMS) for long-acting opioids

What are DESI Drugs?
June 1, 2009

What are DESI Drugs?

Multiple Dosage Strength Products - CMC Considerations
May 11, 2009

Multiple Dosage Strength Products – CMC Considerations

Botanicals: What is the starting material for the API?
March 30, 2009

Botanicals: What is the starting material for the API?

One vs. Two Batches for Single-Dose and Multiple-Dose Studies
March 19, 2009

One vs. Two Batches for Single-Dose and Multiple-Dose Studies

Use of Data from Foreign Clinical Studies for US Approval
February 18, 2009

Use of Data from Foreign Clinical Studies for US Approval

505(b)(2) NDA Labeling
January 15, 2009

505(b)(2) NDA Labeling

505(b)(2) Literature Searches - Too much or too little?
September 15, 2008

505(b)(2) Literature Searches – Too much or too little?

PREA and 505(b)(2)
July 15, 2008

PREA and 505(b)(2)

What Is the Competition for Your Product?
June 1, 2008

What Is the Competition for Your Product?

Paragraph IV Certifications under 505(b)(2)
May 18, 2008

Paragraph IV Certifications under 505(b)(2)

505(b)(2) Patent & Marketing Exclusivity
April 23, 2008

505(b)(2) Patent & Marketing Exclusivity

505(b)(2): Freedom from Generic Competition and Exclusivity Issues
October 28, 2007

505(b)(2): Freedom from Generic Competition and Exclusivity Issues