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Mass Compounding Threatens FDA Enforcement: Column

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An FDA Matters column calls on FDA to fully enforce the laws against mass compounding of approved drugs that are not in shortage.

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...