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March 5, 2020

Office of Generic Drugs: Offices and Divisions

Immediate Office Clinical Safety Surveillance Staff Communications Staff Generic Regulatory Affairs Team Global International Affairs Program Management and Analysis Staff Office of Research and Standards Division […]
March 5, 2020

GDUFA Implementation: Bi-Annual Industry Regulatory Science Work Group Meeting

FDA and representatives of the generic drug industry meet bi-annually to discuss current and emerging regulatory science challenges and concerns. Minutes from these meetings are posted […]
March 5, 2020

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension Usp, 125 Mg/5 Ml due to Possible Underdosing or Overdosing

Summary Company Announcement Date: February 20, 2020 FDA Publish Date: February 21, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Possible underdosing or overdosing […]
March 5, 2020

Patient Listening Sessions

FDA’s Patient Affairs Staff (PAS) in partnership with the National Organization for Rare Disorders (NORD) is excited to host Patient Listening Sessions! Patient Listening Sessions are a […]
March 5, 2020

Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP 30mg/mL, 1mL Fill/2mL Vials Due to the Potential Presence of Small Particulates

Summary Company Announcement Date: March 04, 2020 FDA Publish Date: March 05, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Small […]
March 5, 2020

Health Fraud Scams

Advisory Letters The U.S. FDA issued letters to these companies for illegally marketing products for the treatment or prevention of serious diseases. Thirty days after FDA […]
March 5, 2020

Bulk Drug Substances Used in Compounding

Compounders sometimes produce drugs using bulk drug substances, also known as active pharmaceutical ingredients. For example, when a patient has an allergy to an ingredient in […]
March 5, 2020

Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers

Docket Number: FDA-2017-D-6821 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance is intended to clarify […]
March 5, 2020

Inclusion of Older Adults in Cancer Clinical Trials

Submit Comments by 05/06/2020 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
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