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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 […]
April 20, 2020

Gastrointestinal Drugs Advisory Committee Roster

**Helmut H. Albrecht, MD, MSExpertise: Pharmaceutical MedicineTerm: 11/1/2019–10/31/2023President, H2A Associates, LLCChief Scientific Officer, Alitair Pharmaceuticals, Inc.3350 SW 27th Ave, Executive Tower, Ste 2203Miami, Florida 33133 Christopher […]
April 20, 2020

E2E Pharmacovigilance Planning

Docket Number: FDA-2004-D-0245 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

FDA grants accelerated approval to pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion

On April 17, 2020, the Food and Drug Administration granted accelerated approval to pemigatinib (PEMAZYRE, Incyte Corporation) for the treatment of adults with previously treated, unresectable […]
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