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FDA General

One-Day Inspection Pilot Underway at FDA

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

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Human Drugs

Makary Touts Hiring Push, Clinical Trial Reforms at FDLI

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

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Human Drugs

FDA Releases Bio-Thera Solutions FDA-483

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

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Human Drugs

Commissioners National Priority Voucher for Bizengri

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

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Human Drugs

Guidance on CMC Flexibility for Human CGTs

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

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Human Drugs

FDA Meeting on AI pilot for Early-Stage Clinical Trials

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

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Medical Devices

Guidance On Patient-Matched Guides for Orthopedic Implants

FDA posts a new guidance detailing how manufacturers should design and submit regulatory applications for patient-matched guides used in orthopedic im...

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Human Drugs

Expedite FDA Review of Breakthrough Mental Health Therapies: House Letter

Some 30 bipartisan House members urge FDA to expedite its review of new mental health therapies.

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Medical Devices

Unetixs Vascular Selling Illegal Devices: FDA

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

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Human Drugs

FDA Stresses Sponsor Responsibility in Decentralized Clinical Trials

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