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NEWSROOM CLOSED FOR THE HOLIDAYS

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FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Monday, Jan 5, 2026.

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...

Congressional Dems Want Drug Deal Information

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House and Senate Democratic health leaders ask AstraZeneca, Lilly, Novo Nordisk, and Pfizer for details about the drug pricing dea...

FDA Flags Sterility/Quality Control at SCA Pharma

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FDA cites SCA Pharmaceuticals for multiple deficiencies in sterile drug manufacturing practices following a 10-day inspection of t...