The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
To expedite the evaluation of new drugs and review of marketing applications for drugs addressing unmet medical needs for patients with serious or life-threatening conditions, the FDA has established four expedited programs: Fast Track Designation, Breakthrough Therapy Designation, Priority Review, and Accelerated Approval. This episode examines FDA Expedited Programs with CDER’s Senior Regulatory Expedited Programs Manager, Miranda Raggio.
Listen to the ToxChats Podcast:
Expedited FDA Programs Select ToxChats© podcast episodes are available on iTunes and Google (search ToxChats), in addition, all episodes are on the
ToxChats webpage. The podcasts report on cutting-edge news in toxicological research from around the globe, and feature interviews with experts and a review of current advances. We encourage you to listen to and follow ToxChats. We welcome any feedback or suggestions for future topics.