White Paper

505 (b)(2) vs. ANDA: How Complex Drugs Fit In

Source: Rho

By Samantha Hoopes, PhD, RAC and Sheila Bello-Irizarry, PhD, RAC

ClinicalTrial_concept

Choosing the Appropriate New Drug Application and Corresponding Abbreviated Development Pathway

With the confirmation of a new Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., in 2017, we have seen some changes in the regulatory environment with a new Drug Competition Action Plan and FDA draft guidances focused on introducing more competition into the drug market with the goal of increasing access to drugs that consumers need. These guidance documents are meant to provide information on abbreviated approval pathways and provide clarity on the regulatory pathway for complex generic drugs in order to speed approval allowing for more competition in the market place, which may impact pricing.