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TXT Sentinel Tool Comparable to Protocol-driven Assessment: Study [282 Words] [ Price : $8.95]
FDAs medical product safety surveillance system, Sentinel, passes the first performance test of its modular program tools as part of a multi-effort assessment to validate their usefulness as surveillance measures.
07/27/2016
 
 
TXT DAA Guidance Terminology Change Suggested [2792 Words] [ Price : $8.95]
Stakeholders make specific suggestions to modify an FDA draft guidance on developing direct-acting antiviral drugs to treat hepatitis C.
07/27/2016
 
 
TXT FDA Approves AbbVie NDA for Viekira XR for Hepatitis C [1183 Words] [ Price : $8.95]
FDA approves an AbbVie NDA for Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) tablets, a once-daily, extended-release co-formulation of the active ingredients in Viekira PAK for treating patients with chronic genotype 1 hepatitis C virus infection.
07/27/2016
 
 
TXT FDA Clears Heparin-induced Thrombocytopenia Assay [94 Words] [ Price : $8.95]
FDA clears an Instrumentation Laboratory 510(k) for the HemosIL HIT-Ab(PF4-H) assay for use on ACL TOP Hemostasis Testing Systems for detecting antibodies associated with heparin-induced thrombocytopenia.
07/27/2016
 
 
TXT FDA Posts Generic Drug User Fee Rates [85 Words] [ Price : $8.95]
Federal Register Notice: FDA announces the FT 2017 user fee rates for ANDAs, prior approval supplements, drug master files, generic drug API facilities, and finished dosage form facilities.
07/27/2016
 
 
TXT Guidance on Real-World Evidence to Support Device Decisions [110 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices.
07/27/2016
 
 
TXT Guidance on Device Adaptive Clinical Study Designs [104 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Adaptive Designs for Medical Device Clinical Studies.
07/27/2016
 
 
TXT Panel to Discuss Southern Hemisphere Influenza Vaccine [94 Words] [ Price : $8.95]
Federal Register Notice: FDA plans a meeting of the Vaccines and Related Biological Products Advisory Committee 10/13 to discuss a vaccine for the 2017 southern hemisphere influenza season.
07/27/2016
 
 
TXT Allow Communication on Safe, Effective Drug Use: Industry [2858 Words] [ Price : $8.95]
PhRMA and BIO call for regulatory changes to permit communication of truthful, non-misleading information about drugs.
07/27/2016
 
 
TXT FDA Clears 4WEB Lateral Spine Truss System [96 Words] [ Price : $8.95]
FDA clears a 4WEB Medical 510(k) for its Lateral Spine Truss System, a 3D-printed lateral interbody fusion device.
07/27/2016
 
 
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