What NOT to Do in an FDA Meeting

Many Sponsors come out of a positive-response FDA meeting thinking they have gotten everything they wanted. Unfortunately, the FDA is not obligated to tell you what you missed. Did you get permission to conduct a trial, or did you get confirmation your drug discovery program is on track to receive marketing approval? I’ve seen topContinue reading “What NOT to Do in an FDA Meeting”

Fundamental Concept: Know Your Audience!

The FDA Office of Orphan Products Development (OOPD), the EMA Committee for Orphan Medicinal Products (COMP), and your FDA review division are unique entities with individual characteristics. Care should be taken to ensure any submissions are written with your particular audience in mind.