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April 5, 2022

The ABCs of Product Specific Guidances

What are PSGs:Product-specific guidances (or PSGs for short) describe the Agency’s current thinking on the evidence needed to demonstrate that a generic drug is therapeutically equivalent […]
April 5, 2022

CDER Quality Management Maturity

What’s New 04/05/22 CDER’s Office of Pharmaceutical Quality (OPQ) released a whitepaper on Quality Management Maturity (QMM). To increase transparency and incentivize investment in mature quality […]
April 1, 2022

Best Brand Consumers Products, Inc. Issues Voluntary Recall of Mickey Mouse Hand Sanitizer Ethyl Alcohol 68% Due to Presence of Methanol and the Mandalorian Hand Sanitizer Ethyl Alcohol 68% Due to the Presence of Benzene

Summary Company Announcement Date: April 01, 2022 FDA Publish Date: April 01, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Methanol in […]
April 1, 2022

F&S Medical Supply, DBA Pink Toyz Issues Voluntary Nationwide Recall of Pink Pussycat Capsules Due to the Presence of Undeclared Sildenafil

Summary Company Announcement Date: April 01, 2022 FDA Publish Date: April 01, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil Company Name: […]
April 1, 2022

FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma

On April 1, 2022, the Food and Drug Administration approved axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for adult patients with large B-cell lymphoma (LBCL) that is […]
April 1, 2022

Development Considerations of Antimicrobial Drugs for the Treatment of Uncomplicated Urinary Tract Infections (UTI) (Virtual) – 06/03/2022

On This Page Date: June 3, 2022 Time: 9:00 AM – 5:00 PM ET DESCRIPTION/SUMMARY This public workshop is currently being scheduled and planned as a […]
April 1, 2022

FDA CDER & NIH NCATS Regulatory Fitness in Rare Disease Clinical Trials Workshop – 05/16/2022

On This Page Date: May 16 – 17, 2022 Day1: Mon, May 16 9:00 AM – 4:00 PM ET Day2: Tue, May 17 9:00 AM – […]
April 1, 2022

Give Your Community a Boost: Combatting Misinformation Through Communication and Research

Image By: RADM Richardae Araojo, Pharm.D., M.S., Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity April is National […]
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