On This Page Date: February 28, 2024 Time: 9:00 AM – 11:30 AM ET Topics & Presentations Speakers Expanding Generic Drug Access Through International Engagements Unlocking […]

AnazaoHealth Corporation, Las Vegas, NV Jaclyn Wong800-995-4363Ext=3120 9/23/2014 12/17/2023 7/29/2022 Yes No Regulatory Meeting Held 5/2/2023 Yes Annovex Pharma, Inc., Lorton, VA Adedayo Akinbi1-571-642-5262 10/14/2021 3/06/2024 […]

Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products  August 17, 2023   Podcast (7:30 min, 10.3MB, MP3)Transcript Insights About the FDA/EMA Parallel Scientific […]

On This Page Date: April 23, 2024 Time: 9:00 AM – 5:00 PM ET Description and Summary The Food and Drug Administration is holding a virtual […]

On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase […]

Govvi WOW! contains hidden ingredient 12/21/2023 Public Notification: Phentamene XT contains hidden drug ingredient 5/05/2023 Public Notification: NORF 20 contains hidden drug ingredients 5/01/2023 Public Notification: […]

FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) […]

To encourage innovation and competition in the market for biological products and facilitate the development of biosimilars and interchangeable biosimilars, FDA has developed the Biosimilars Action […]

Office of Communications10001 New Hampshire AveHillandale Building, 4th FlSilver Spring, MD 20993 Toll Free (855) 543-3784 (301) 796-3400 Hours Available CDER Division of Drug Information