Medical Device Legal News with Sam Bernstein: Episode 11
Recent FDA actions offer long-awaited clarity on what constitutes a ‘minor change’ to solid oral OTC dosage forms, providing manufacturers with a clearer pathway for certain modifications while maintaining a measured,...more
The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles...more