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April 21, 2020

FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act

Docket Number: FDA-2019-D-4751 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Oncology Center of Excellence Office of Medical Products and Tobacco, Center for […]
April 21, 2020

FDA Regional Implementation Specifications for ICH E2B(R3) Reporting to the FDA Adverse Event Reporting System (FAERS)

Docket Number: FDA-2016-D-1280 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research The technical specifications document is to […]
April 20, 2020

Coronavirus (COVID-19) Update: Daily Roundup April 20, 2020

For Immediate Release: April 20, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
April 20, 2020

B. Braun Medical Inc. Issues Voluntary Nationwide Recall of One (1) Lot of Ceftazidime for Injection USP and Dextrose Injection USP (50 mL), Duplex Container Due to Out-of-Specification Results for High Molecular Weight Polymers

Summary Company Announcement Date: April 17, 2020 FDA Publish Date: April 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Out-of-Specification Results for High […]
April 20, 2020

Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples

Summary Company Announcement Date: April 20, 2020 FDA Publish Date: April 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Particulate Matter […]
April 20, 2020

Enforcement Policy — OTC Sunscreen Drug Products Marketed Without an Approved Application

Docket Number: FDA-2010-D-0509 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance describes FDA’s enforcement approach […]
April 20, 2020

E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials

Docket Number: FDA-2017-D-6113 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
April 20, 2020

The Path Forward: Coronavirus Treatment Acceleration Program

Image By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs, Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research and Janet Woodcock, M.D., […]
April 20, 2020

Webinar: The FDA Study Data Technical Conformance Guide v4.4 – Nov 22, 2019 – 11/22/2019 – 11/22/2019

On This Page Date: November 22, 2019 Time: 1:00 PM – 2:30 PM ET Follow us on LinkedIn [embedded content] View Slides This on-demand webinar is […]
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