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Last updated 1 day ago
FDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood Disorder
2 days ago
The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new...
FDA Approves Stelara for Pediatric Ulcerative Colitis
2 days ago
The U.S. Food and Drug Administration has approved Stelara (ustekinumab) injection for...
FDA Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop: Using Modeling and Simulation to Select Dosages for Combination Therapies and New Indications - 11/09/2023
2 days ago
This workshop is intended for interested parties regarding ongoing efforts; parties interested...
Mitigating Risks from Human Xylazine Exposure - 10/04/2023
2 days ago
Mitigating Risks from Human Xylazine Exposure
Partnership for DSCSA Governance (PDG)/FDA Joint Public Meeting: DSCSA Stabilization Period Midway Checkpoint - 06/17/2024
2 days ago
This meeting serves as a checkpoint midway in the stabilization period, affording...
Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products - 05/19/2026
2 days ago
Learn directly from the FDA’s regulatory experts in medical product centers: drugs...
2024 PDA/ FDA Joint Regulatory Conference - 09/09/2024
2 days ago
The FDA and Parenteral Drug Association (PDA) are leveraging their combined strengths...
Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development - 10/12/2023
2 days ago
The applications of physiologically-based pharmacokinetic (PBPK) absorption modeling and simulation (M&S) have...
Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice - 03/05/2024
2 days ago
On March 5th, 2024, FDA is conducting a public workshop to discuss...
FDA/CDER Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop: Using Modeling and Simulation to Evaluate the Effects of Intrinsic and Extrinsic Factors - 10/16/2023
2 days ago
This workshop is intended for parties interested in continued advocacy for alternatives...
12th Annual Global Summit on Regulatory Science - 10/19/2022
2 days ago
12th Annual Global Summit on Regulatory Science. Registration for the Global Summit...
Patent Certifications and Suitability Petitions
2 days ago
Information on patents and suitability petitions that impact the availability of generic...