Small pharmaceutical companies are at a distinct disadvantage when it comes to understanding and accessing the process for new or generic drug approval. Many of these companies have one person fulfilling many roles, and their teams may have limited direct experience with one or more aspects of the approval process. The Small Business and Industry Assistance (SBIA) section of CDER helps fill this gap by providing information and resources on human drug development and regulation. They offer newsletters, webinars, tutorials, workshops, and direct answers to questions sent via phone and email to all members of the regulated pharmaceutical industry. Good examples of their offerings include the Clinical Investigator Training Course to be held this month or the CDERLearn course “Best Practices for Communication Between FDA and IND Sponsors During Drug Development”. You can access their many learning opportunities here.

Text Copyright © 2018 Katrina Rogers