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November 23, 2020

Fusion Health and Vitality Issues Voluntary Nationwide Recall of Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 Due to the Unapproved Use of a Food Additive and Unapproved Marketing Statements

Summary Company Announcement Date: November 22, 2020 FDA Publish Date: November 23, 2020 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Unapproved new drug […]
November 23, 2020

Why the United States-Mexico-Canada Agreement is Important to FDA

Image By: Anne Kirchner, J.D., and Joseph Rieras, J.D., Senior Advisors in FDA’s Office of Trade, Mutual Recognition, and International Arrangements FDA was an important member […]
November 23, 2020

CDER Compliance Conference – 01/14/2021 – 01/14/2021

On This Page Date: January 14, 2021 Time: 8:30 AM – 4:30 PM ET This conference is FREE. In SBIA’s first conference dedicated to compliance, participants […]
November 22, 2020

Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

For Immediate Release: November 21, 2020 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered […]
November 20, 2020

FDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies

For Immediate Release: November 20, 2020 Today, the U.S. Food and Drug Administration approved Zokinvy (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford […]
November 20, 2020

Dr. Hahn’s Remarks to the Meeting of the Regulatory Affairs Professionals Society (RAPS) – 11/17/2020

Speech by Stephen M. Hahn, M.D. Leadership Role Commissioner of Food and Drugs – Food and Drug Administration (Remarks as prepared for delivery) Good afternoon.  I’m […]
November 20, 2020

Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry

Submit Comments by 02/22/2021 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 […]
November 19, 2020

Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine

Summary Company Announcement Date: November 19, 2020 FDA Publish Date: November 19, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Cross Contamination with Lidocaine […]
November 19, 2020

Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

For Immediate Release: November 19, 2020 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with […]
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