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Welcome to FDAweb Pay Per View Search our 45,661 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 Next >>   Court Sides With FDA in Regen Menaflex 510(k) Rescission [211 Words] [ Price : $7.95] A federal court rules that FDA acted properly and within its statutory authority when it reclassified ReGen Biologics Menaflex knee repair device and rescinded the company’s 510(k). 04/15/2013     FDA Approves Taro’s Topicort Topical Spray [107 Words] [ Price : $7.95] FDA approves a Taro Pharmaceutical Industries NDA for Topicort (desoximetasone) Topical Spray. 04/15/2013     FDA Drug Compounding Alert on Eve of Hearing [231 Words] [ Price : $7.95] On the eve of FDA commissioner Margaret Hamburg appearing before a Congressional hearing to answer questions on the agency’s oversight of drug compounding pharmacies, the agency issues a safety alert on sterile drug products made by two pharmacy compounders. 04/15/2013     FDA Finds ‘Inappropriate Conditions’ at 31 Drug Compounders [1003 Words] [ Price : $7.95] Recent FDA investigations at 31 high-volume, mechanized “compounding pharmacies” producing sterile drugs in 18 states find “inappropriate conditions for sterile processing and other practices that create risk of contamination.” 04/12/2013     FDA OKs Warner Chilcott’s Doryx 200mg Tablet [67 Words] [ Price : $7.95] FDA approves Warner Chilcott’s 200mg strength of Doryx (doxycycline hyclate) delayed-release tablets. 04/12/2013     FDA Guidance on Device Classification Product Codes [189 Words] [ Price : $7.95] FDA finalizes a guidance on medical device classification product codes that are used to assist in accurate identification and tracking of current medical devices. 04/12/2013     FDA Grants Elorac Fast Track for Naloxone Topical Lotion [146 Words] [ Price : $7.95] FDA grants Elorac fast track status for naloxone topical lotion and its use for relieving pruritus in patients with cutaneous T-cell lymphoma. 04/12/2013     FDA Accepts Otsuka NDA for Kidney Disease Drug [164 Words] [ Price : $7.95] FDA accepts for priority review an Otsuka Pharmaceutical Co. NDA for tolvaptan and its use in treating autosomal dominant polycystic kidney disease. 04/12/2013     ICH Guidance on DNA Reactive Impurities [324 Words] [ Price : $7.95] A new International Conference on Harmonization guidance provides a “practical framework” that can be applied for the identification, categorization, qualification, and control of mutagenic impurities. 04/12/2013     FDA Says Stryker Cutting Guides Recall is Class I [159 Words] [ Price : $7.95] FDA classifies a Stryker Corp. recall as Class 1 for its ShapeMatch Cutting Guides indicated to assist in positioning total knee replacement components during surgery, because of possibility of manufacturing error. 04/11/2013     << Prev  23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42  Next >>

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