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CDER Right-to-Try Summaries Can Go Thru Portal

[ Price : $8.95]

CDER updates its CDER NextGen Portal to allow Right to Try annual summary submissions for CDER-regulated products.

Guide on Tech Specs for NASH Drug Data Sets

[ Price : $8.95]

FDA posts a final guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic...

FDA Promotes Centralized Statistical Trial Monitoring

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FDA encourages drug sponsors to use centralized statistical monitoring to help keep an eye on clinical trial integrity issues.

McKinsey & Co. Pays $650 Million in Opioid Case

[ Price : $8.95]

McKinsey & Co. agrees to pay $650 million to settle both criminal and civil investigations into its advisory work with Purdue Phar...

FDA Sees New Ocaliva Liver Injuries

[ Price : $8.95]

FDA says it has identified serious liver injuries in patients without cirrhosis of the liver being treated for primary biliary cho...

Keros Halts Some Dosing in Cibotercept Trial

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Keros Therapeutics stops some dosing in a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy i...

FDA Hasnt Inspected Factory with Recalls: ProPublica

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A detailed ProPublica investigative report says FDA failed to inspect a Glenmark Pharmaceuticals facility in India that had multip...

Trump Unclear on Abortion Pills in Interview

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In a Time interview, president-elect Donald Trump said it has always been his commitment to preserve access to abortion pills, but...

Generics Seek Legislation to End Drug Sameness Delays

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The Association for Accessible Medicines urges Congress to pass pending legislation to allow FDA to disclose sameness information ...

FDA Launches RWE Evidence Innovation Center

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FDA launches the CDER Center for Real-World Evidence Innovation with four areas of initial focus.