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In its latest batch of Warning Letters, FDA cites Medsource, New Dawn Nutrition, Specialty Medicine Compounding, and Ultroid Techn...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Controlled Correspondence Related to Generic Drug Development.[ Price : $8.95]
Federal Register Notice: FDA releases an ICH guidance: E6(R2) Good Clinical Practice.[ Price : $8.95]
Federal Register Notice: FDA publishes a list of 13 PMAs that have been approved including safety and effectiveness summaries.[ Price : $8.95]
Federal Register Notice: FDA issues a priority review voucher to Wellstat Therapeutics for the pediatric disease product applicati...[ Price : $8.95]
Federal Register Notice: FDA determines that Pondimin and Ponderex were withdrawn from sale for reasons of safety or effectiveness...[ Price : $8.95]
Federal Register Notice: FDAs Cellular, Tissue, and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee w...[ Price : $8.95]
FDA accepts for priority review an Eisai supplemental NDA for Halaven (eribulin mesylate) and its use in treating patients with in...