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FDA Town Hall on Quality Management System Regulation

[ Price : $8.95]

FDA announces a 1/14 town hall to discuss its Quality Management System Regulation (QMSR) and its effective date of 2/2/2026.

13 Potential New FAERS Drug Safety Signals

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FDA releases a list of 13 potential safety signals identified in drugs between 7/2025 and 9/2025.

First Cycle Review Metrics Debated at PDUFA Session

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In a PDUFA 8 reauthorization subgroup discussion, FDA and industry representatives trade data and evaluations of first-cycle revie...

FDA Tumult Keeps Makary Under Microscope: NYT Article

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The New York Times reports that ongoing turmoil at FDA has increasingly placed commissioner Marty Makary under the microscope, rai...

FDA Cites GSK Hungary Vaccine Plant

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FDA cites a GlaxoSmithKline biologicals manufacturing site in Hungary for significant lapses in deviation investigations and mater...

Catalent Issued 2 FDA Form 483s

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FDA posts two separate Form 483 inspection reports citing a range of quality and compliance deficiencies at Catalent Maryland, Inc...

AstraZeneca Pulling Andexxa From Market Due to Safety

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A new FDA safety update says safety risks associated with AstraZenecas Andexxa outweigh the drugs benefits, leading the agency to ...

FDA Seeks Alternate Path to Fed Contracting for Tech Access

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FDA seeks input on a new way to contract directly with venture capitalbacked innovators in an effort to possibly speed adoption of...

FDA Guidance on Bioresearch Monitoring Inspections

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FDA posts an updated guidance outlining its processes for bioresearch monitoring inspections, which oversee the conduct, reporting...

Is Political Pressure Corrupting New FDA Voucher Program?

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FDA faces Increased scrutiny of its newly established Commissioners National Priority Review voucher program, which is intended to...