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Attorney Questions Sovereign Warning Letter on OTC Directions

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Attorney Kurt Karst says a 2013 Dallas District Office Warning Letter to Sovereign Pharmaceuticals raises more questions than it a...

Drug Compounder Recalls 2 Drug Lots

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Park Pharmacy & Compounding Center recalls two lots of methylcobalamin 5mg/ml 30ml Amber Vials and Multitrace-5 Concentrate 10ml A...

Grant Funds Available for CDER Data Standards

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Federal Register Notice: FDA makes available grant funds to support the CDER Data Standards Program.

Guidance on ANDA Stability Testing

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Federal Register Notice: FDA releases a draft guidance: ANDAs: Stability Testing of Drug Substances and Products, Questions and An...

QS Violations Found in Zeppessis Reprocessing Inspection

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FDAs Seattle District Office warns Zeppessis Reprocessing about many Quality System violations in its reprocessing of Stryker Nept...

Latest FDA Warning Letters

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In it latest batch of Warning Letters, FDA cites Axium Healthcare Pharmacy, Inc. dba Balanced Solutions Compounding Pharmacy, Best...

Axium Warned About Multiple Drug Compounding Violations

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FDAs Florida District Office warns Axium Healthcare Pharmacy about multiple violations at its drug compounding facility.

FDA Seeks Research Proposals on Regulatory Science

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FDA says it has an open solicitation seeking proposals for advanced research and development for regulatory science activities.

FDA Breakthrough Status for Catalyst LEMS Drug

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FDA grants Catalyst Pharmaceutical Partners a breakthrough therapy designation for its investigational product Firdapse (amifampri...

Feds Sue South Dakota Eye Drop Manufacturer

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Dakota Laboratories agrees to resolve federal litigation and follow a consent decree acknowledging that it is no longer manufactur...