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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 […]
October 20, 2021

FDA issues refuse-to-file letter for application for Barth syndrome

FDA recognizes the devastating nature of Barth syndrome for young patients and their families, the unmet medical need for these patients, and the urgency to make […]
October 19, 2021

Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Methocarbamol 500mg Bottles Due to Mislabeling With the Incorrect Strength

Summary Company Announcement Date: October 18, 2021 FDA Publish Date: October 19, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Bottles labeled as Methocarbamol […]
October 19, 2021

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

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

Jon B. Cole, MD – 611902 – 05/05/2021

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Product: Drugs Recipient: Jon B. Cole, MD Hennepin County Medical Center 701 Park AvenueMinneapolis, MN 55415-1623United States […]
October 19, 2021

Lauren R. Klein, MD, M.S. – 605544 – 05/06/2021

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Product: Drugs Recipient: Lauren R. Klein, MD, M.S. Hennepin County Medical Center 701 Park Avenue, #MC-825Minneapolis, MN […]
October 19, 2021

Sircle Laboratories, LLC – 615098 – 09/21/2021

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Bobby J. King, Jr. Recipient Title President Sircle Laboratories, LLC P.O. Box 238Ridgeland, MS 39158United States […]
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