Ogle Cattle Company, Inc. – 713311 – 09/05/2025
New Animal Drug/Adulterated
Pamela K. Den Besten, DDS, MS/University of California, San Francisco – 715245 – 09/19/2025
Clinical Investigator (Sponsor)
Persōn & Covey, Inc. – 711191 – 09/23/2025
CGMP/Finished Pharmaceuticals/Adulterated
April – June 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
April – June 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System…
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024 – 09/12/2024
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024
Advancing Generic Drug Development: Translating Science to Approval 2024 – 09/24/2024
Advancing Generic Drug Development: Translating Science to Approval 2024
Quality and Regulatory Predictability: Shaping USP Standards – 12/11/2025
This discussion will show how USP public standards strengthen quality, streamline development, support regulatory compliance, and overall, increase regulatory predictability…
CDER Quantitative Medicine Center of Excellence (QM CoE)
The Center for Drug Evaluation and Research Quantitative Medicine Center of Excellence is established to facilitate and coordinate the continuous…
About the Quantitative Medicine Center of Excellence (QM CoE)
To ensure the CoE is equipped to carry out its mission, the CoE will be governed by leadership from the…
Natco Pharma Limited – 672564 – 09/25/2025
CGMP/Finished Pharmaceuticals/Adulterated