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November 22, 2021

GDUFA Science and Research Outcomes for Fiscal Year 2020

As part of the enhanced accountability and reporting commitments in the Generic Drug User Fee Amendments of 2017 (GDUFA II), FDA prepares annual outcome reports on the extent to which GDUFA science and […]
November 22, 2021

FDA Health Playbook

Remove the Risk Visit Disposal of Unused Medicines to learn how to get rid of unused or expired drugs. [embedded content] Transcript FDA Health Playbook – Remove the Risk […]
November 22, 2021

Transcript FDA Health Playbook – Remove the Risk

Narrator (Voiceover):  Hall of Fame Defensive Back, Darrell Green Darrell Green:  I’m here with a winning play for your home team. Keep your playing field safe […]
November 22, 2021

Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Levetiracetam Injection, USP Due to Lack of Sterility Assurance

Summary Company Announcement Date: November 19, 2021 FDA Publish Date: November 22, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Lack of sterility assurance […]
November 19, 2021

FDA is temporarily suspending certain Clozapine REMS program requirements to ensure continuity of care for patients taking clozapine

[Updated 11/19/2021] Health care professionals continue to alert FDA about ongoing difficulties with the Clozapine REMS program, including a high call volume and long call wait […]
November 19, 2021

American Screening LLC issues a Voluntary Nationwide Recall of American Screening Hand Sanitizer Packaged in 8 oz Bottles Because They Resemble Beverage Containers

Summary Company Announcement Date: November 19, 2021 FDA Publish Date: November 19, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Hand sanitizer is packaged […]
November 19, 2021

FDA Approves First Drug to Improve Growth in Children with Most Common Form of Dwarfism

For Immediate Release: November 19, 2021 Today, the U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age […]
November 19, 2021

Drug Permeability: Best Practices for Biopharmaceutics Classification System-Based Biowaivers – 12/06/2021 – 12/06/2021

On This Page Date: December 6, 2021 Time: 8:30 AM – 4:20 PM ET Date:  December 6, 2021  Time:  8:30 a.m. to 4:20 p.m.  Location:  Virtual  […]
November 18, 2021

Updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products

FDA issued a guidance for industry, Control of Nitrosamine Impurities in Human Drugs, in September 2020 to help ensure the safety of the U.S. drug supply by […]
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