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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...

FDA Lifts Partial Clinical Hold on MacroGenics Cancer Study

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FDA removes partial clinical hold against MacroGenics Phase 2 LINNET study evaluating the investigational cancer therapy lorigerli...

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.

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...

Groups Urge Congress to Advance Generic Drug Bills

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Healthcare advocacy organizations call on key House lawmakers to hold hearings and advance bipartisan legislation aimed at lowerin...