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Surmasis Pharmaceutical CGMP Violations Found

[ Price : $8.95]

FDA warns Surmasis Pharmaceutical about CGMP violations in its production of finished drugs.

QS Issues Found at American Contract Systems

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FDA warns American Contract Systems about Quality System violations in its work as a medical device manufacturer and contract ster...

Drug Safety Alert on Novartis MS Drug Gilenya

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A new FDA drug safety alert warns that when Novartis multiple sclerosis drug Gilenya (fingolimod) is stopped, the disease can beco...

Sanders, Khanna Plan Drug Price Relief Legislation

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Sen. Bernie Sanders and Rep. Ro Khanna say the will introduce legislation aimed at forcing drug companies to reduce the price for ...

FDA Approves Elite Pharma Generic Norco

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FDA approves an Elite Pharmaceuticals ANDA for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets).

New Info Collection on Cosmetic GMP Survey

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Federal Register notice: FDA submits to OMB a new information collection entitled Survey of Current Manufacturing Practices for th...

Comments Sought on Drug Sponsor Disseminated Software

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Federal Register notice: FDA seeks comments on a proposed framework for regulating software applications disseminated by or on beh...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include American Contract Systems, Product Packaging and Surmasis Pharmaceut...

FDA Wants to Be 1st to Find Device Safety Signals

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FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren discuss steps being taken to ensure that FDA is consistently the ...

Angiotensin II Receptor Blocker Impurities Q&A

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FDA posts questions and answers about the presence of suspected carcinogenic impurities in some generic versions of valsartan drug...