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Welcome to FDAweb Pay Per View Search our 45,668 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 Next >>   FDA Says No to Generic HalfLytely Due to Ischemic Colitis [205 Words] [ Price : $7.95] Citing ischemic colitis concerns, FDA denies a petition to allow ANDAs for generic copies of Braintree’s HalfLytely (10 mg bisacodyl) Bowel Prep Kit product. 04/29/2013     Appeals Court Rules for FDA in Seroquel Exclusivity Case [249 Words] [ Price : $7.95] An appeals court rules in FDA’s favor and affirms a lower court decision that gave deference to the agency when it decided that a supplemental NDA for AstraZeneca’s was not entitled to any additional marketing exclusivity. 04/29/2013     Blockade Medical Gains Clearance for Barricade Coil System [81 Words] [ Price : $7.95] FDA clears a Blockade Medical 510(k) for the Barricade Coil System for treating a variety of morphologies. 04/29/2013     CDRH Mulls Changes to 510(k) Modifications Process [314 Words] [ Price : $7.95] As part of CDRH’s 510(k) revamp initiative, the Center moves attention to device modifications and when these require new 510(k)s. 04/26/2013     FDA Clears NinePoint’s NvisionVLE for Esophageal Imaging [75 Words] [ Price : $7.95] FDA grants 510(k) clearance to NinePoint Medical for its Nvision VLE Imaging System for esophageal tissue microstructure. 04/26/2013     FDA OKs R-Tech Ueno IND Severe Dry Eye Treatment [75 Words] [ Price : $7.95] FDA approves an IND application from R-Tech Ueno for Phase 1/2 trials of its RU-101 ophthalmic solution for treating dry eye. 04/26/2013     Hospira Recalls 1 Lot of Sodium Chloride [95 Words] [ Price : $7.95] Hospira recalls one lot of 0.9% sodium chloride injection, USP, 100 mL, flexible container after confirming a customer complaint involving particulate issues. 04/26/2013     Appeals Court Rules for Preemption in Generic Reglan Case [249 Words] [ Price : $7.95] Citing federal preemption grounds, an Iowa appeals court affirms several lower court decisions dismissing a failure-to-warn lawsuit by an injured plaintiff taking generic Reglan. 04/26/2013     FDA Warns on Bogus Botox [212 Words] [ Price : $7.95] An FDA drug safety alert warns about fraudulent versions of Allergan’s Botox being sold to U.S. medical practices. 04/26/2013     FDA Class 1 Recall for Infant Masks [94 Words] [ Price : $7.95] FDA classifies as Class 1 an Engineered Medical Systems recall of its SealFlex Single Port Ribbed Mask (Infant) due to mislabeling. 04/26/2013     << Prev  10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29  Next >>

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