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TXT 86 Drug Safety Labeling Changes Posted [3054 Words] [ Price : $8.95]
FDA releases safety labeling changes approved in May for 86 drugs.
06/16/2016
 
 
TXT Another Amgen BPCIA Suit Against Sandoz [2712 Words] [ Price : $8.95]
Amgen files another suit against Sandoz over that company’s aBLA for a biosimilar form of Amgen’s Neulasta.
06/16/2016
 
 
TXT FDA Clears SpineGuard Pedicle Screw Placement System [1184 Words] [ Price : $8.95]
FDA clears a SpineGuard 510(k) for the PediGuard Threaded DSG device for use in pedicle screw insertion.
06/16/2016
 
 
TXT Benefit-Risk Guidance for Device Enforcement [82 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.
06/16/2016
 
 
TXT Guidance on ISO Biological Evaluation of Devices [182 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Use of International Standard ISO 10993-1, `Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process.’
06/16/2016
 
 
TXT Pediatric Clinical Investigator Workshop [171 Words] [ Price : $8.95]
Federal Register Notice: FDA’s will hold a public workshop 9/12-13: “Pediatric Clinical Investigator Training.”
06/16/2016
 
 
TXT Pediatric Oncology Subcommittee to Meet [187 Words] [ Price : $8.95]
Federal Register Notice: FDA’s Pediatric Oncology Subcommittee will meet 6/28-6/29 to discuss pediatric development for six products in development for adult cancer and an unmet clinical need in a certain brain tumor.
06/16/2016
 
 
TXT FDA, Catalyst Agree on Confirmatory Phase 3 Trial [1195 Words] [ Price : $8.95]
FDA and Catalyst Pharmaceuticals reach agreement on a confirmatory Phase 3 study protocol for Firdapse (amifampridine phosphate), indicated for the symptomatic treatment of Lambert-Eaton myasthenic syndrome.
06/16/2016
 
 
TXT FDA Grants Vanda 3 Years Exclusivity for Fanapt sNDA [1195 Words] [ Price : $8.95]
FDA grants Vanda Pharmaceuticals three years marketing exclusivity due to a supplemental NDA approved last month for Fanapt (iloperidone) that modified and expanded its prescribing information for use as a maintenance treatment for schizophrenia in adults.
06/16/2016
 
 
TXT FDA Accepts Spectral PMA Module for Toraymyxin [1228 Words] [ Price : $8.95]
FDA accepts and reviews a Spectral Medical pre-clinical module for Toraymyxin, an investigational therapeutic hemoperfusion device that removes endotoxin from the bloodstream.
06/16/2016
 
 
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