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Court Tosses California Pay for Delay Ban

[ Price : $8.95]

A California federal judge says a state law banning pay-for-delay generic drug agreements likely violates out-of-state commerce pr...

Info Collection on Expanded Access

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Federal Register notice: FDA seeks comments on an information collection revision entitled Expanded Access to Investigational Drug...

Califf Vows War on Social Media Rx Promos

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FDA commissioner nominee Robert Califf says, if confirmed, he is going to be very aggressive on curbing social media medical misin...

Draft Guide on Bowel Cleansing Products

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Federal Register notice: FDA makes available a draft guidance entitled Bowel Cleansing for Colonoscopy: Efficacy and Safety Consid...

Pediatric Anti-infective Drug Guidance

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Federal Register notice: FDA makes available a final guidance entitled Development of Anti-Infective Drug Products for the Pediatr...

Impurities Guide on Residual Solvents

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Federal Register notice: FDA makes available a final guidance for industry entitled Q3C (R8) Impurities: Guidance for Residual Sol...

House Report Slams Drug Pricing, Patent Manipulating

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A U.S. House Oversight and Reform Committee staff report alleges troubling issues with drug companies rising prices and actions to...

Urotronic PMA Approved for Urethral Strictures

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FDA approves an Urotronic PMA for Optilume Urethral Drug Coated Balloon for use in male urethral strictures.

FDA Panel Knocks Down Ischemic Stroke Device

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An FDA advisory committee votes 7 to 3 that a BrainsGate PMA for its Ischemic Stroke System did not demonstrate that the devices b...

Draft Guide on Rhinosinusitis Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs ...