Skip links

US FDA 505(b)(2) NDA clinical, CMC and regulatory strategy concepts to expedite drug development

May 15, 2023

William Salminen, PhD, DABT, PMP, VP, Nonclinical Safety and Toxicology
Olu Aloba, PhD, Vice President, CMC Services
Angela Drew, PhD, Vice President, Regulatory Affairs

Agnieszka Marcinowicz, PhD, Senior Manager, Pharmacokinetics
Madelyn Huang, PhD, DABT, Toxicologist

The 505(b)(2) NDA pathway can reduce drug development costs and accelerate the time to market by leveraging existing public data using clinical bridging and regulatory strategies. Whether or not a drug qualifies for the 505(b)(2) pathway depends on the active ingredient, drug formulation, clinical indication and other factors. Clinical programs can be streamlined and accelerated, and confer unique marketing benefits, such as exclusivity, depending on the regulatory strategy and product. Considerations for chemistry, manufacturing and controls (CMC) and the unique manufacturing issues that can arise owing to the accelerated development of 505(b)(2) drug products are also discussed.

Click to read more in Drug Discovery Today

Drug Discovery Today, May 2023. © Elsevier Ltd. All rights reserved.