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One-Day Inspection Pilot Underway at FDA

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FDA launches a pilot program using one-day inspectional assessments as part of a broader effort to modernize its oversight model a...

Makary Touts Hiring Push, Clinical Trial Reforms at FDLI

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FDA commissioner Marty Makary says the agency is undertaking a major hiring push and a series of operational reforms aimed at stre...

FDA Releases Bio-Thera Solutions FDA-483

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FDA releases the form FDA-483 with six observations from an inspection at Chinas Bio-Thera Solutions.

Commissioners National Priority Voucher for Bizengri

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FDA awards Partner Therapeutics a Commissioners National Priority Voucher for a new Bizengri indication.

Guidance on CMC Flexibility for Human CGTs

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FDA publishes a guidance explaining how the agency uses a flexible chemistry, manufacturing, and controls approach to help expedit...

FDA Meeting on AI pilot for Early-Stage Clinical Trials

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FDA hosts a virtual public meeting later this month to address industry questions tied to a planned pilot program exploring the us...

Unetixs Vascular Selling Illegal Devices: FDA

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FDA warns Unetixs Vascular about illegally marketing adulterated and misbranded vascular diagnostic ultrasound devices.

FDA Stresses Sponsor Responsibility in Decentralized Clinical Trials

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FDA reaffirms support for decentralized clinical trials (DCTs) while making clear that moving trial activities outside traditional...

Makary Defends FDA Drug Decisions

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FDA commissioner Marty Makary forcefully defends the agency against mounting criticism of recent drug rejections, arguing the agen...

CareFusion Hit With Warning at Texas Drug Facility

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FDA sends a Warning Letter to CareFusion, citing widespread and repeat violations of current good manufacturing practice regulatio...