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June 22, 2020

UPDATED PUBLIC PARTICIPATION INFORMATION: July 14, 2020: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement – 07/14/2020 – 07/14/2020

On This Page Date: July 14, 2020 Time: 9:00 AM – 1:30 PM ET UPDATED INFORMATION (as of 6/22/2020): The public participation information has been changed […]
June 19, 2020

January – March 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Bridion (sugammadex) injection Arteriospasm coronary (coronary vasospasm) FDA is evaluating the need for regulatory action. Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Thrombocytopenia The “Contraindications,” “Warnings […]
June 19, 2020

How to Report a Shortage or Supply Issue

Please see our new website:Drug Shortages Database Search For Industry: Send FDA Drug Shortage and Supply Notifications Industry can notify FDA Drug Shortage Staff via CDER […]
June 19, 2020

FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem

[6/19/2020] FDA advises consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol (wood […]
June 19, 2020

Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing

Docket Number: FDA-2020-D-1136 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Biologics Evaluation and Research Center for Drug Evaluation and Research FDA plays […]
June 19, 2020

Project 1600 Inc. – 608349 – 06/18/2020

Product: Drugs Recipient: Recipient Name Dennis Michael Lynch Project 1600 Inc. 501 Montauk HwyBox 704Amagansett, NY 11930United States [email protected] Date:               June 18, 2020 TO:    […]
June 19, 2020

8th Annual Scientific Computing Days (SCD) – 09/29/2020 – 09/30/2020

On This Page Date: September 29 – 30, 2020 Time: 8:30 AM – 5:00 PM ET Image Summary: The FDA Scientific Computing Board (SCB) in partnership […]
June 19, 2020

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Summary Company Announcement Date: March 18, 2019 FDA Publish Date: March 18, 2019 Product Type: DrugsGeneric Drugs Reason for Announcement: Recall Reason Description Presence of particulate […]
June 19, 2020

GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children’s Robitussin® Honey Cough and Chest Congestion DM and Children’s Dimetapp® Cold and Cough Due to Dosing Cups Missing Some Graduation Markings

Summary Company Announcement Date: June 18, 2020 FDA Publish Date: June 18, 2020 Product Type: DrugsOver-the-Counter Drugs Reason for Announcement: Recall Reason Description Incorrect dosing cups […]
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