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No FDA-Approved Products with Kratom: Gottlieb

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FDA commissioner Scott Gottlieb cautions that the agency has not approved any products containing kratom and is taking action agai...

Ways to Improve FDA Unapproved Drugs Initiative

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Researchers suggest ways to improve generic competition for previously unapproved drugs that have gained FDA approval under the ag...

Multiple Violations Found at RTI Surgical

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FDA warns RTI Surgical about multiple violations in its continuing manufacture of a bone graft product that is regulated as a drug...

Prostatic Artery Embolization Device into Class 2

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Federal Register notice: FDA classifies the prostatic artery embolization device into Class 2 (special controls).

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Lupin Ltd., ProSun International and RTI Surgical.

Trump Nominates Alex Azar as Next HHS Secretary

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President Donald Trump nominates former Eli Lilly executive Alex Azar as the next HHS secretary, replacing former Rep. Tom Price, ...

Pharmacy Owner Pleads Guilty in $100 Million Compounding Fraud

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The president and owner of a Florida pharmacy pleads guilty for his role in a $100 million compounding pharmacy fraud scheme, whic...

Theravance/Mylan NDA for COPD Drug

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Theravance Biopharma and Mylan NV file an NDA for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist as a...

Hospital Group Urges FDA to Help More with Product Shortages

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The American Hospital Association urges FDA to intervene and expedite the resolution of the worsening shortages of small-volume pa...

Test for Detecting Blood in Stool Cleared

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FDA clears a Clinical Genomics and Quest Diagnostics 510(k) for its InSure One, an at-home collection, fecal immunochemical test i...