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August 10, 2020

Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act

Docket Number: FDA-2018-D-4615 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]
August 10, 2020

H-Lab Life – 609528 – 08/07/2020

Product: Drugs Recipient: H-Lab Life 3270 Suntree Boulevard, Suite 1103Melbourne, FL 32940United States [email protected] Issuing Office: Center for Drug Evaluation and Research | CDER United States […]
August 10, 2020

FDA-NRC Workshop Enhancing Development of Emerging Technologies: Radiopharmaceuticals and Radiological Devices – 10/14/2020 – 10/14/2020

On This Page Date: October 14, 2020 Time: 9:00 AM – 4:30 PM ET Topics for Discussion Overview of Regulatory Process for Marketing and Licensing of […]
August 10, 2020

User Fee Lists

Annual facility fees and Generic Drug Applicant Fees are due October 1st of each applicable FY. Content current as of: 08/10/2020 Regulated Product(s) Topic(s)
August 10, 2020

Soluciones Cosméticas Issues Voluntary Nationwide Recall of Bersih Hand Sanitizer Gel Due to The Potential Presence of Undeclared Methanol (Wood Alcohol): Updated August 7, 2020

Summary Company Announcement Date: August 09, 2020 FDA Publish Date: August 09, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Methanol Contamination Company […]
August 7, 2020

FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings

For Immediate Release: August 07, 2020 Today, the U.S. Food and Drug Administration approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe […]
August 7, 2020

Incredible Products Sa De Cv Issues Voluntary Nationwide Recall of Gelbac T Antibacterial Handgel

Summary Company Announcement Date: August 06, 2020 FDA Publish Date: August 07, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Methanol Contamination Company Name: […]
August 7, 2020

ITECH 361 Issues Voluntary Nationwide Recall of All Clean Hand Sanitizer and Moisturizer and Disinfectant Due to The Potential Presence of Undeclared Methanol (Wood Alcohol)

Summary Company Announcement Date: July 06, 2020 FDA Publish Date: July 06, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of methanol […]
August 7, 2020

FDA approved the product labeling for PREZCOBIX and EVOTAZ for use in pediatric patients

FDA approved changes to the product labeling for PREZCOBIX (darunavir/cobicistat) for use in pediatric patients weighing at least 40 kg and changes to the product labeling […]
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