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House Committee Would Limit Foreign Trial Data

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Five Hogan Lovells attorneys say a House Appropriations Committee report could prohibit FDA from accepting drug IND trial data fro...

10 Observations in Somerset Therapeutics FDA-483

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FDA releases the form FDA-483 with 10 observations from a 2025 inspection at Indias Somerset Therapeutics Private Limited.

New CDER Biologics Compliance Program Explained

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Two Alston & Bird attorneys give a comprehensive analysis of the new CDER compliance program for pre-license and preapproval inspe...

Report says Makary May Face Ouster Amid White House Tensions

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Media reports suggest FDA commissioner Marty Makarys time at FDA may be limited due to White House tension over his management of ...

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...