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Latest posts
Last updated about 15 hours ago
Drug Shortages | Additional News and Information
about 15 hours ago
Drug Shortages: Additional News and Information
Rare Diseases at FDA
about 16 hours ago
The FDA works with many people and groups, such as patients, caregivers...
Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts
about 16 hours ago
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed...
Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805
about 18 hours ago
Activities Report of the Generic Drug Program | FDARA Title VIII Sections...
Spotlight on CDER Science
about 18 hours ago
FDA scientists carry out laboratory, clinical and analytical research to address knowledge...
FDA grants accelerated approval to zanidatamab-hrii for previously treated unresectable or metastatic HER2-positive biliary tract cancer
about 20 hours ago
On November 20, 2024, the FDA granted accelerated approval to zanidatamab-hrii (Ziihera...
Upholding Public Trust: FDA Office of Criminal Investigations’ Crucial Role in Bringing Drug Criminals to Justice
about 23 hours ago
For more than 30 years, OCI investigators have been conducting and coordinating...
Drug Trials Snapshot: LUMISIGHT
about 23 hours ago
LUMISIGHT is a drug used for fluorescence imaging in adults with breast...
Mxbbb Issues Voluntary Nationwide Recall of Umary Acid Hyaluronic Due to the Presence of Diclofenac and Omeprazole
2 days ago
MXBBB is voluntarily recalling 1 lot of UMARY ACID HYALURONIC, 30 CAPLETS...
Antimicrobial Resistance
2 days ago
Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to...
FDA Drug Competition Action Plan | Improving the efficiency of the generic drug development, review, and approval process
2 days ago
By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers...