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Welcome to FDAweb Pay Per View Search our 45,628 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers          << Prev  32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 Next >>   Alimera Sciences Resubmits Iluvien NDA [191 Words] [ Price : $7.95] pSivida Corp. says that its licensee, Alimera Sciences, has submitted its response to a second FDA Complete Response Letter on Iluvien for chronic diabetic macular edema. 04/01/2013     BioMarin BLA Submitted for Vimizim [140 Words] [ Price : $7.95] BioMarin Pharmaceutical files a BLA for Vimizim ( elosulfase alfa), an enzyme replacement therapy for treating patients with mucopolysaccharidosis Type IVA. 04/01/2013     Appeals Court Dismisses Warning Letter Challenge [211 Words] [ Price : $7.95] An appeals court affirms a lower court decision that QLaser Healing Light managing partner Robert Lytle cannot challenge an FDA Warning Letter until he has exhausted all remedies under the Administrative Procedures Act. 04/01/2013     FDA Comment Letter on BioCryst’s Peramivir [233 Words] [ Price : $7.95] FDA sends a preliminary comment letter to BioCryst Pharmaceuticals that outlines a pathway by which the firm could file an NDA for intravenous peramivir. 04/01/2013     New SUPAC Drug Manufacturing Addendum [295 Words] [ Price : $7.95] A new FDA draft guidance on manufacturing scale-up and post-approval changes eliminates earlier lists of manufacturing equipment from previous related guidances. 04/01/2013     Guidance on Formal FDA Meetings with Biosimilar Sponsors [92 Words] [ Price : $7.95] Federal Register Notice: FDA releases a draft guidance, Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants. 04/01/2013     FDA Makes Revised SUPAC Guidance Available [102 Words] [ Price : $7.95] Federal Register Notice: FDA releases a revised guidance, SUPAC: Manufacturing Equipment Addendum. 04/01/2013     IoM Workshop Examines Clinical Data Transparency [326 Words] [ Price : $7.95] A recent Institute of Medicine workshop on clinical data sharing acknowledged opportunities where data could be shared to help improve public health and enhance patient safety. 03/29/2013     FDA ‘Agnostic’ on Choice of Abuse-deterrents for Opioids [735 Words] [ Price : $7.95] CDER deputy director Douglas Throckmorton tells an FDLI meeting the agency “agnostic” about which abuse-deterrent technologies for opioids industry should use. 03/29/2013     BE Guidance on Metronidazole Vaginal Gel [4 Words] [ Price : $7.95] Federal Register Notice: FDA releases a draft guidance on bioequivalence recommendations for metronidazole vaginal gel. 03/29/2013     << Prev  32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51  Next >>

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