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Last updated 1 day ago
FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer
1 day ago
On July 31, 2026, the Food and Drug Administration approved lutetium Lu...
Advancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products - 09/10/2026
1 day ago
This half-day virtual workshop features FDA expert presentations and audience Q&A on...
Drug Registration and Listing Instructions
2 days ago
FDA adopts the use of Extensible Markup Language (XML) files for the...
Developing and Manufacturing Drugs Including Biologics
2 days ago
This material is intended to be a helpful resource that consolidates information...
Companies that Have Not Submitted Drug Amount Reports
2 days ago
Registrants that failed to provide annual amount reporting for calendar year 2024...
OTC Monograph Reform: OMOR Format and Content & Electronic Submissions - 08/22/2023
2 days ago
OTC Monograph Reform: OMOR Format and Content & Electronic Submissions
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 - 09/12/2024
2 days ago
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023 - 09/28/2023
2 days ago
SBIA Conference/Workshop: Electronic Drug Registration and Listing (eDRLS) Using CDER Direct -...
Selection of Appropriate SPL Codes for Human Prescription Drug Labeling
2 days ago
Selection of Appropriate SPL Codes for Human Prescription Drug Labeling (for SPL...
FDA Drug Competition Action Plan
2 days ago
FDA's Drug Competition Action Plan (DCAP) encourages robust and timely market competition...
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
2 days ago
This guidance provides recommendations for the design and conduct of studies to...