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November 8, 2021

Remarks by Acting Commissioner Janet Woodcock to the 2021 GRx+Biosims Conference – 11/08/2021

It is a pleasure to be with you for this year’s GRx+Biosim meeting and to join with my colleagues in sharing some of the important work […]
November 5, 2021

URGENT: Envy Me Is Recalling LaBri’s Body Health Atomic 60 Capsules Due To Undeclared Sibutramine

Summary Company Announcement Date: March 27, 2017 FDA Publish Date: February 09, 2018 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeling Company Name: Envy […]
November 5, 2021

CPG Sec. 110.100 Certification for Exports (Withdrawn 11/04/2021)

Docket Number: FDA-1996-D-0405 Issued by: Guidance Issuing Office Office of Regulatory Affairs Center for Food Safety and Applied Nutrition Compliance Policy Guide Sec. 110.100 was withdrawn […]
November 5, 2021

OTC Monograph Reform: OTC Sunscreen Drugs – 12/15/2021 – 12/15/2021

On This Page Date: December 15, 2021 Time: 3:00 PM – 4:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR On […]
November 5, 2021

OTC Monograph Reform: Deemed Final Orders – 12/15/2021 – 12/15/2021

On This Page Date: December 15, 2021 Time: 1:00 PM – 2:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR This […]
November 4, 2021

CPG Sec. 110.100 Certification for Exports

Issued by: Guidance Issuing Office Office of Regulatory Affairs Center for Food Safety and Applied Nutrition Compliance Policy Guide Sec. 110.100 was withdrawn November 4, 2021 […]
November 3, 2021

Modernization of the FDA CDER Export Certificate Program

On Dec. 3, 2021, the FDA Center for Drug Evaluation and Research (CDER) will begin issuing electronic Certificates of Pharmaceutical Product (eCPPs) and will no longer […]
November 3, 2021

FDA Actions to Remove Unapproved Drugs from the Market by Drug

Ascorbic acid injection Cocaine hydrochloride solution products Dehydrated Alcohol Isometheptene-containing drugs Isoxsuprine Local anesthetics Meperidine hydrochloride and promethazine hydrochloride drugs Otic drugs Federal Register notice: Unapproved […]
November 3, 2021

FDA Notification Regarding Isoxsuprine Hydrochloride Drug Products

On July 15, 2020, FDA announced the final decision of the Commissioner of Food and Drugs, that Vasodilan containing isoxsuprine hydrochloride lacked substantial evidence, consisting of adequate and well-controlled studies, to be effective for specific indications. Vasodilan containing isoxsuprine hydrochloride was part of the Drug […]
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