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July 17, 2020

Hydroxychloroquine-online.com – 607727 – 07/09/2020

Product: Drugs Issuing Office: Center for Drug Evaluation and Research | CDER United States RE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United […]
July 16, 2020

Lannett Issues Voluntary Nationwide Recall of Levetiracetam Oral Solution, 100mg/Ml Due to Microbial Contamination

Summary Company Announcement Date: December 18, 2019 FDA Publish Date: December 18, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Bacillus subtilis Company Name: […]
July 16, 2020

Generic Drug Research Collaboration Opportunities

The FDA Office of Generic Drugs implements the GDUFA Regulatory Science Research Program by collaborating within FDA as well as externally through grants or contracts.  Contracts […]
July 16, 2020

CDER Pilot Grant Program: Standard Core Clinical Outcome Assessments (COAs) and their Related Endpoints

Patient input can help inform the therapeutic context for regulatory review. Patient input also can inform the selection of clinical outcomes, ensure the appropriateness of instruments […]
July 16, 2020

Division of Pediatric and Maternal Health

About Us The Division of Pediatric and Maternal Health (DPMH) is located in the Office of New Drugs.  DPMH oversees quality initiatives which promote and necessitate […]
July 15, 2020

Drug Trials Snapshots: DOJOLVI

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
July 15, 2020

Guidance Snapshot Pilot

GUIDANCE SNAPSHOTS AT A GLANCE FDA guidance documents contain the Agency’s current best thinking on a particular topic. To support transparent communication and dissemination of FDA guidance […]
July 14, 2020

Soluciones Cosméticas Issues Voluntary Nationwide Recall of Bersih Hand Sanitizer Gel Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)

Summary Company Announcement Date: July 14, 2020 FDA Publish Date: July 14, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Methanol Contamination Company […]
July 14, 2020

AAA Cosmética, S.A. de C.V. Issues Voluntary Nationwide Recall of all Lots Within Expiry of bio aaa Advance Hand Sanitizer 480 mL Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)

Summary Company Announcement Date: July 14, 2020 FDA Publish Date: July 14, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Undeclared Methanol Contamination […]
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