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Latest posts
Last updated 43 minutes ago
Safety Labeling Change Orders
about 1 hour ago
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)...
FDA to Address Unused Opioids in American Homes
about 2 hours ago
The U.S. Food and Drug Administration today issued a Request for Information...
FDA approves drug for pediatric patients with most common form of dwarfism
about 18 hours ago
FDA approves drug for pediatric patients with most common form of dwarfism
GDUFA Type II API DMF Payment Receipts Report
about 18 hours ago
GDUFA Type II API DMF Payment Receipts Report
Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop - 06/08/2026
about 18 hours ago
This workshop provides an overview of the status of science and research...
Endothelin Receptor Antagonist REMS Information
about 20 hours ago
FDA has determined that a REMS is no longer necessary to ensure...
Drug Trials Snapshots: MYQORZO
about 20 hours ago
MYQORZO is a cardiac myosin inhibitor used for treatment of adults with...
Over-The-Counter Monograph Drug User Fee Program (OMUFA)
about 23 hours ago
A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would...
October 5, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 10/05/2023
1 day ago
October 5, 2023: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
National Drug Code Format
1 day ago
FDA’s final rule, Revising the National Drug Code Format and Drug Label...
Artri Ajo Rey and Artri Ajo King may be harmful due to hidden drug ingredients
1 day ago
The Food and Drug Administration is advising consumers not to purchase or...