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Latest posts
Last updated about 19 hours ago
FDA Holds Meeting with States on Importation of Lower Cost Drugs
about 19 hours ago
FDA held a meeting with several states to discuss the section 804...
Drug Shortages | Additional News and Information
about 22 hours ago
Drug Shortages: Additional News and Information
Check Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
about 23 hours ago
Prescription drugs should only be purchased from wholesale drug distributors licensed in...
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection
1 day ago
Responding to FDA Form 483 Observations at the Conclusion of a Drug...
Newly Added Guidance Documents
1 day ago
Guidance documents represent the FDA's current thinking on a particular subject. New...
Activities Report of the Generic Drug Program (FY 2025) – FDARA Title VIII Sections 807 and 805
1 day ago
Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the...
Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805
1 day ago
Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the...
Patient-Focused Drug Development Glossary
2 days ago
This glossary defines terms that will be used in the series of...
Oncology (Cancer)/Hematologic Malignancies Approval Notifications
2 days ago
FDA does not issue approval announcements for every approval or drug label...
FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma
2 days ago
On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli...
Premium Health Management Inc. dba Premium Health - 721474 - 02/20/2026
2 days ago
Failure to Register and List/Misbranded
Safety Labeling Change Orders
2 days ago
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)...