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FDA Budget Proposal Signals Push for Tighter Ad Oversight

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Law firm Sheppard breaks down some of FDAs proposals in its budget documents that industry should keep a close eye on, including n...

Workshop on Novel Surrogate Endpoints for Rare Disease Drugs

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FDA announces a 5/18 virtual public workshop aimed at advancing the use of novel surrogate endpoints in developing treatments for ...

Insmed Halts Brensocatib Program After Mid-Stage Trial Miss

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Insmed discontinues development of its drug candidate brensocatib for hidradenitis suppurativa after a mid-stage clinical trial fa...

See Supply Chain Strategy as Core Regulatory Function: Attorney

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Baker Hostetler attorney Winston Kirton says life sciences companies that are active in both the U.S. and the EU need to change th...

FDA Not Keeping Pace with Non-Oncology Basket Trials: Column

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A Clinical Trial Vanguard online column explains how a 2022 FDA master protocol guidance has not kept pace with non-oncology baske...

Doctor Failed to Follow Investigational Plan: FDA

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FDA warns Newport Beach, CA-based physician Ehsan Sadri about failing to follow the investigational plan in two clinical trials.

Workshop on Improving Pregnancy Drug Safety Registries

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FDA plans a two-day public workshop next month aimed at improving how pregnancy registries are designed and used to assess the saf...

Organogenesis Advances ReNu Toward FDA Filing After Key Meeting

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Organogenesis says it has reached agreement with FDA that clears the way for a rolling BLA submission for its knee osteoarthritis ...

Medline Industries QS Violations Cited

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FDA warns Glens Falls, NY-based Medline Industries about Quality System violations in its manufacturing and assembly of cardiovasc...

FDA Opens READI-Home Innovation Challenge

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FDA solicits applications for its new READI-Home innovation challenge to use medical technology in the home to reduce or prevent h...