On This Page Date: March 7, 2024 Time: 1:00 PM – 2:30 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR The […]

Stage 1 PQ/CMC FHIR Implementation Guide on the May 2024 HL7 Ballot: The Stage 1 FHIR Implementation Guide (IG) “Pharmaceutical Quality – Chemistry, Manufacturing and Controls […]

The FDA Compounding Quality Center of Excellence offers instructor-led trainings, in-person or virtually, to outsourcing facilities with limited space for pharmacy compounders and regulators. These multi-day […]

Helping Guide the Way for New Medicines Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When […]

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 […]