Defined by the US Food and Drug Administration (FDA) as a strategic development process tool, the Target Product Profile (TPP) “embodies the notion of beginning with the goal in mind.”[1] Broadly, the TPP is a template that summarizes key drug labeling concepts to focus discussions
As we noted in a separate blog post, the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed to treat rare diseases. However,
The ultimate goal of any drug development program is to obtain regulatory approval with the desired prescribing information. Beyond that, developers hope to obtain this approval in the shortest amount of time and with the most efficient use of resources. In an article published in
Throughout the lifecycle of a drug development program, sponsors are confronted with a range of key questions. They must decide on the correct… Regulatory pathway, FDA center, Key Opinion Leaders (KOLs), Target Product Profile (TPP) inclusions, Data to rely on, Studies to conduct, Indication and
Whether you plan to out-license or commercialize your product, getting the label right matters. When putting together a comprehensive drug development plan, it’s important to remember one of Premier Consulting’s key approaches to drug development: “Begin with the end in mind.” This is a multifactorial
Oncology patients face a difficult journey — a frightening diagnosis followed by intricate and oftentimes burdensome treatment regimens with uncertain outcomes. One patient struggles to take the correct dosage at the prescribed times through the “brain fog” caused by his cancer. Another’s livelihood is at
In a previous blog post, we discussed some significant changes to over-the-counter (OTC) product regulations put into place by the passage and signing into law of the CARES Act. The previous post focused on the most attention-getting OTC component of the new law: the introduction
To get a successful return on investment (ROI) for your product, it is essential to establish early in the process: Is there an unmet need for the product? Which attributes will the product need to access the market? Will providers and patients be receptive to
It is a widely held tenet that market exclusivity is essential for the successful launch of a new drug. But is this always the case? For products approved through the FDA 505(b)(2) pathway, is pursuing the 3-year period of exclusivity available through Hatch-Waxman always necessary?
As we have noted in this blog previously, under the Pediatric Research Equity Act (PREA), all new drug applications for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration are required to contain an assessment of the
In order to fulfill a requirement specified in Section 745A(a) of the Food and Drug Administration Safety and Innovation Act (aka FDASIA), FDA recently issued a draft guidance directing mandatory use of electronic filing and formatting for most regulatory submissions which currently can still be submitted
With the tsunami of activities connected with the initial implementation of all the GDUFA requirements, another change made by FDA went largely under the radar. FDA released the draft guidance, “Pre-Launch Activities Importation Requests (PLAIR)”. (CDER July 2013) which describes how an NDA/ANDA applicant may
The goal of drug product development is commercial success. If this statement wasn’t true, how would patients access the life-saving or life-enhancing drugs we are developing? Yet, all too many companies focus just on FDA approval, which in our view should be just a very
When Premier Consulting was young, products approved under 505j were called “generics” and 505(b)(1) “new drugs.” There was no consensus name for products approved via 505(b)(2). Of course, at the time there had been very few 505(b)(2) products approved. By now, we have seen an
One anomaly to the exclusivity rules is that a combination drug product containing a new chemical entity (NCE) and one or more previously approved drugs does not receive the 5-year exclusivity that a single-component NCE drug would receive. Thus, Ferring Pharmaceuticals Prepopik (sodium picosulfate, citric
Announcement of the decision from the US Court of Appeals for the Second Circuit in the United States v. Alfred Caronia generated a lot of discussion this past week, as well it might. The appellate court overturned the criminal conviction of pharmaceutical sales representative Alfred
It’s happened in most generic product development programs: A likely looking drug product candidate is selected and the due diligence begins. A review of the Orange Book shows one or more “use code” patents listed for the RLD. A review of the actual patent reveals
ViroPharma has pulled out all stops to prevent generic copies of its off-patent Vancocin® capsule (vancomycin hydrochloride) including the use of the Citizen Petition process. Recently, FDA denied most of the requests in their Citizen Petition and simultaneously approved generics from 3 companies. ViroPharma immediately
A recent editorial (may need subscription) in the New York Times opined that a recent Supreme Court decision – a “bizarre outcome” – “makes it virtually impossible to sue generic manufacturers for failing to provide adequate warning of a prescription drug’s dangers.” The court case the
I was honored to be invited to speak at the FDA-OCRA 12th Annual Educational Conference in Irvine California on June 10, 2009. I was asked to discuss and compare the 505(b)(2) and ANDA Suitability Petition. I thought I should share this topic with the readers
A draft label be included with all NDA submissions. For a 505(b)(2) NDA, where do you get the information for this label? What labeling is required? What is labeling? Well, the “label” is what is on the immediate container of the drug product and can
IP attorney Stephen Albainy-Jenai and I just concluded a webinar hosted by DIA entitled 505(b)(2) Patent & Exclusivity. 23 different companies attended, showing the increasing interest in 505(b)(2) issues. Earlier this year, DIA hosted my overview of the 505(b)(2) drug development process where the attendees had many questions asking
