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9 Bulk Drugs Proposed for Compounding Exclusion

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Federal Register notice: FDA seeks comments on nine bulk drug substances that it is proposing not to allow outsourcing facilities ...

Concept Medical Breakthrough Status on MagicTouch

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FDA grants Concept Medical a breakthrough device designation for MagicTouch AVF, a sirolimus drug-coated balloon catheter for trea...

Akari Therapeutics Gains Orphan Status for Nomacopan

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FDA grants Akari Therapeutics an orphan drug designation for nomacopan and its use in treating hematopoietic stem cell transplanta...

Regulatory Review Period for Pumas Nerlynx

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Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Puma Bios Nerlynx (neratini...

Could Sharpless Get Trumped by HHS Asst. Secretary?

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The Trump Administration mulls FDA acting commissioner Ned Sharpless time at the agency, and without a nomination to move him into...

FDA Seeks Move to New Duodenoscopes

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An FDA safety alert recommends that healthcare providers transition to duodenoscopes with innovative designs that are more safe an...

2 Medical Device Benefit/Risk Guidances

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FDA issues two final guidances explaining its views on making benefit/risk determinations for certain medical device approval appl...

8 Observations on Dr. Reddys FDA-483

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FDA issues an FDA-483 with eight observations from an inspection at Dr. Reddys drug manufacturing facility in Andhra, Pradesh, Ind...

Tourettes Drug Gains Fast Track Status

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FDA grants Emalex Biosciences a fast track designation for its investigational drug ecopipam for treating patients with Tourette S...

OPDP Electronic Submission Webinar

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A CDER Office of Prescription Drug Promotion Webinar discusses contents of a recent guidance on providing promotional labeling and...