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October 25, 2021

UPDATED TIME INFORMATION: November 4, 2021: Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) Meeting Announcement – 11/04/2021 – 11/04/2021

On This Page Date: November 4, 2021 Time: 10:00 AM – 4:00 PM ET UPDATED TIME INFORMATION: UPDATED INFORMATION (as of October 22, 2021): Time: The […]
October 22, 2021

Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA) – 11/16/2021 – 11/16/2021

On This Page Date: November 16, 2021 Time: 9:00 AM – 2:00 PM ET FDA is announcing a virtual public meeting to discuss proposed recommendations for […]
October 22, 2021

Coronavirus (COVID-19) Update: October 22, 2021

For Immediate Release: October 22, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
October 22, 2021

CANCELLED October 28, 2021: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement – 10/28/2021 – 10/28/2021

On This Page Date: October 28, 2021 Time: 10:30 AM – 3:00 PM ET UPDATED INFORMATION (as of October 22, 2021): The meeting of the Oncologic […]
October 21, 2021

Pregnant? Breastfeeding? Better Drug Information Is Coming

Image Español Women and their health care providers can look forward to getting more useful and up-to-date information over the next few years about the effects […]
October 21, 2021

FDA and Center for Research on Complex Generics Co-Hosted Workshop: Establishing the Suitability of Model-Integrated Evidence to Demonstrate Bioequivalence for Long-Acting Injectable and Implantable Drug Products  – 11/30/2021 – 11/30/2021

On This Page Date: November 30, 2021 Time: 8:30 PM – 5:30 PM ET Date:   November 30, 2021  Time:   8:30 am – 5:30 pm EST  Workshop […]
October 21, 2021

Data Standards for Drug and Biological Product Submissions Containing Real-World Data

Submit Comments by 01/21/2022 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 […]
October 20, 2021

Remarks by Acting Commissioner Woodcock to the 2021 NORD Breakthrough Summit – 10/19/2021

Speech by Janet Woodcock, M.D. Acting Commissioner of Food and Drugs – Food and Drug Administration Good morning.  I’m delighted to be with you again. As […]
October 20, 2021

Merck Issues Voluntary Nationwide Recall of CUBICIN® (Daptomycin for Injection) 500 mg, Lot 934778, Due to Presence of Particulate Matter Identified as Glass Particles

Summary Company Announcement Date: October 19, 2021 FDA Publish Date: October 20, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains particulate matter […]
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