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Over 1,000 BIMO Inspections in FY 2023

[ Price : $8.95]

An FDA report on bioresearch monitoring FY 2023 metrics documents nearly 1,100 inspections through FDAs five Centers.

Novartis Wins Generic Entresto Approval Stay

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The United States Court of Appeals for the DC Circuit grants a Novartis motion to stay FDAs approval of MSN Laboratories generic v...

FTC Supports FDA Draft on Interchangeable Biosimilars

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The Federal Trade Commission says it supports an FDA draft guidance easing the approval requirements for interchangeable biosimila...

GAO Sees Actions, Challenges in Device Surveillance

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The Government Accountability Office says FDA has faced challenges in its preparations for beginning active postmarket surveillanc...

Reps Seek FDA Action on Drug Research in China

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Four House Democrats and Republicans urge FDA to take a greater role in protecting U.S. national security interests that could be ...

Significant CGMP Violations at Eugia Pharma

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FDA warns Indias Eugia Pharma Specialties about CGMP violations in its production of finished drugs.

LDT Power Grab Suit Filed Against FDA

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The Association for Molecular Pathology and a pathologist sue FDA to block implementation of the agencys final rule asserting regu...

Lillys Tirzepatide Curbs Progression to Diabetes

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Eli Lilly says data from its SURMOUNT-1 study showed that tirzepatide contributed to significant weight loss and delayed in progre...

Post Timely De Novo Summaries: Law Firm

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A Hyman, Phelps & McNamara medical device regulatory expert and attorney say FDA needs to improve the timeliness of its posting of...

ICU Medical Expands Class 1 Recall of Infusion Pumps

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ICU Medical expands a Class 1 recall of its Plum 360, Plum A+ and Plum A+3 Infusion Systems to update the use instructions due to ...