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Revised Compounding MOU for States

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Federal Register notice: FDA makes available for public comment of a revised draft document entitled Memorandum of Understanding A...

Meeting on Drug Shortage Root Causes

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Federal Register notice: FDA announces a 11/27 public meeting entitled Identifying the Root Causes of Drug Shortages and Finding E...

Trump Admin Taps Inside Counsel as Top FDA Lawyer

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Trump Administration senior associate counsel to the president Stacy Cline Amin moves to FDA to serve as chief counsel.

FDA to Meet with Patients Advocating LASIK Ban

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After years of resistance, FDA agrees to meet this week with injured LASIK patients seeking a ban on the lasers used in the contro...

Panel to Review Shire Constipation NDA

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Federal Register notice: FDA announces a 10/18 Gastrointestinal Drugs Advisory Committee meeting to review a Shire NDA for a const...

Guide on Post-approval Drug Substance Changes

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FDA posts a draft guidance entitled Postapproval Changes to Drug Substances.

Cefzil Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Corden Pharma Latinas Cefzil (cefprozil) tablets, 250mg and 500mg mg, and Cefzil for ...

FDA Approves Tevas Opioid Dependence Drug

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FDA approves a Teva 505(b)(2) NDA for Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid...

More Data Needed on Glaxo COPD Add-on Drug

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FDA issues GlaxoSmithKline a complete response letter for its supplemental BLA for mepolizumab as an add-on treatment to inhaled c...

Masimo Acoustic Respiration Sensor for Infants Cleared

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FDA clears a Masimo 510(k) for the RAS-45, an acoustic respiration sensor for its Rainbow Acoustic Monitor (RAM) for infant and ne...