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Panel Meeting on Durect NDA for Bupivacaine

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Federal Register notice: FDA announces a 1/16 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss a Durec...

Carestream Dual-Energy Imaging Cleared

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FDA clears a Carestream 510(k) for its Dual-Energy imaging technology and its Focus 35C Detector with Image Suite Software for med...

Apicore Wants Specific Study for Penicillamine BE

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Apicore asks FDA to require a specific bioequivalence test for ANDAs citing the companys penicillamine capsules.

eCTD Promotion Submission Errors

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CDER OPDP lead project manager Jason Cober reviews in a Webinar the types of errors being seen in promotional submissions in eCTD ...

Trump Stalls Action on e-Cigarettes/Vaping

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President Donald Trump pulls back administration plans to issue new rules on e-cigarettes/vaping to curb youth access, reportedly ...

Apothecus Combination Product CGMP Issues

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FDA warns Apothecus Pharmaceutical about CGMP violations in the production of combination products.

CGMP Violations Found in Torrent Inspection

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FDA warns Torrent Pharma about CGMP and other violations in its production of finished pharmaceuticals.

Carolina Liquid Adulterated, Misbranded Reagents

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FDA warns Carolina Liquid Chemistries about manufacturing and distributing adulterated and misbranded reagents.

Public Meeting on Clinical Outcome Assessments

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Federal Register notice: FDA announces a 12/5 public meeting entitled 2019 Public Meeting on CDER Standard Core Sets: Clinical Out...

Animal Drug Compounding Guidance

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FDA issues a draft guidance with its thinking on enforcement discretion for animal drug compounding from bulk drug substances.