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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 […]
November 19, 2020

OPDP Frequently Asked Questions (FAQs)

Consumer-Directed AdvertisementsDrug of ChoiceDrug Name SizeFDA-Approved Launch Information“New”Package InsertsPost-marketing ReportingPresentation of InformationPress ReleasesPre-distribution SubmissionsReminder AdvertisementsMiscellaneous Questions Consumer-Directed Advertisements What are the general requirements for prescription drug advertisements […]
November 19, 2020

Pro Breath MD, LLC dba Dentist Select and OraCare – 610686 – 11/18/2020

Product: Drugs Recipient: Pro Breath MD, LLC dba Dentist Select and OraCare 467 Martino Twins LaneBridgeport, WV 26330United States [email protected] Date:              November 18, 2020 RE:                  […]
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