Rob Seo and Raja Agnani discuss the specific hurdles of getting FDA clearance for medical devices like condoms and the associated manufacturing inspections.
Rob Seo and Raja Agnani discuss the specific hurdles of getting FDA clearance for medical devices like condoms and the associated manufacturing inspections.
Aaron Alpeter explains the FDA process for sunscreens, which are classified as over-the-counter drugs rather than cosmetics, leading to a slower approval timeline.
Cristina Brooks Potts discusses the complexity and long timeline of pursuing a New Drug Application (NDA) and getting ingredients monographed by the FDA.