Articles tagged with Regulatory from PMD http://www.pmdcentral.com/regulatory/topic/1141/ Articles tagged with Regulatory from PMD Biodel Announces Name Change for Lead Product Candidate Currently under review by the U.S. Food and Drug Administration http://www.pmdcentral.com/biodel-announces-name-change-for-lead-product-candidate/article/178040/ Wed, 01 Sep 2010 09:05:49 GMT pSivida Announces Iluvien® Receives FDA Priority Review for Treatment of Diabetic Macular Edema Reduces the review time goal from 10 months to six months http://www.pmdcentral.com/psivida-announces-iluvien-receives-fda-priority-review-for-treatment-of-diabetic-macular-edema/article/177929/ Tue, 31 Aug 2010 09:46:48 GMT GSK and Valeant Announce New U.S. FDA PDUFA Goal Date for Ezogabine Original PDUFA goal date was August 30, 2010 http://www.pmdcentral.com/gsk-and-valeant-announce-new-us-fda-pdufa-goal-date-for-ezogabine/article/177930/ Tue, 31 Aug 2010 09:51:55 GMT FDA Accepts Sanofi Pasteur's Application to Expand Indication of Menactra® Vaccine to Infants and Toddlers New Indication Seeks to Help Protect Infants and Toddlers Against Meningococcal Disease http://www.pmdcentral.com/fda-accepts-sanofi-pasteurs-application-to-expand-indication-of-menactra-vaccine-to-infants-and-toddlers/article/177558/ Thu, 26 Aug 2010 09:16:12 GMT FDA panel recommends broader use of Eli Lilly's Cymbalta Committee votes positively regarding the overall safety profile of Cymbalta http://www.pmdcentral.com/fda-panel-recommends-broader-use-of-eli-lillys-cymbalta/article/177219/ Fri, 20 Aug 2010 09:38:51 GMT DUSA Pharmaceuticals Receives Response From FDA on Orphan Drug Designation Status Orphan Drug Designation must target a disease that affects fewer than 200,000 patients in the U.S. http://www.pmdcentral.com/dusa-pharmaceuticals-receives-response-from-fda-on-orphan-drug-designation-status/article/176483/ Fri, 06 Aug 2010 12:23:37 GMT Prochymal New Drug Submission Granted Priority Review by Health Canada Health Canada to add first-in-class stem cell therapy to Register of Innovative Drugs providing eight years of market exclusivity http://www.pmdcentral.com/prochymal-new-drug-submission-granted-priority-review-by-health-canada/article/174989/ Wed, 21 Jul 2010 09:57:31 GMT FDA Accepts AFREZZA Complete Response Resubmission FDA Sets Target Action Date of December 29, 2010 http://www.pmdcentral.com/fda-accepts-afrezza-complete-response-resubmission/article/174992/ Wed, 21 Jul 2010 10:26:54 GMT NeuroPace Submits PMA Application for FDA Approval of Novel Investigational Device for Epilepsy Pivotal Trial Data Demonstrate RNS System Met Primary Endpoints by Significantly Reducing Seizures with Positive Safety Profile http://www.pmdcentral.com/neuropace-submits-pma-application-for-fda-approval-of-novel-investigational-device-for-epilepsy/article/174246/ Fri, 09 Jul 2010 09:38:28 GMT Winston Laboratories, Inc. Submits NDA for CIVANEX® (Civamide Cream) for Treatment of Osteoarthritis Also awaiting approval in the European Union and Canada http://www.pmdcentral.com/winston-laboratories-inc-submits-nda-for-civanex-civamide-cream-for-treatment-of-osteoarthritis/article/174061/ Wed, 07 Jul 2010 09:49:07 GMT