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TXT Device Security Should Start in Design: FDA [2851 Words] [ Price : $8.95]
CDRH associate director Suzanne Schwartz says medical device manufacturers should build cyber security into their devices at the design stage.
09/14/2017
 
 
TXT ICH Genomic Sampling Guidance to be Implemented [2673 Words] [ Price : $8.95]
FDA says an ICH guidance on genomic sampling and data has passed Step 4 and is being implemented.
09/14/2017
 
 
TXT Court Says Essure Suit is Preempted [2747 Words] [ Price : $8.95]
Attorney Rachel Weil says a New Your federal court has ruled that a liability suit against Bayer over its Essure birth control device is preempted by federal law.
09/14/2017
 
 
TXT FDA Approves Mvasi Biosimilar of Avastin [2699 Words] [ Price : $8.95]
FDA approves Amgen’s Mvasi, a biosimilar to Genentech’s Avastin, for treating multiple forms of cancer.
09/14/2017
 
 
TXT In Vitro Diagnostic Device Characteristics Guidance [2697 Words] [ Price : $8.95]
FDA issues a guidance to facilitate study designs establishing performance characteristics of in vitro diagnostic devices intended for detection or detection and differentiation of HPV.
09/14/2017
 
 
TXT FDA Approves Expanded COPD Use for Symbicort [1178 Words] [ Price : $8.95]
FDA approves AstraZeneca’s asthma therapy Symbicort (budesonide/formoterol fumarate dihydrate) inhalation aerosol 160/4.5 micrograms to reduce exacerbations of chronic obstructive pulmonary disease.
09/14/2017
 
 
TXT Mobile Medical App Cleared for Substance Use Disorder [263 Words] [ Price : $8.95]
FDA permits under its de novo process the marketing of the first mobile medical application to help treat substance use disorders.
09/14/2017
 
 
TXT Microneedling Device Guidance Out [2630 Words] [ Price : $8.95]
FDA releases a draft guidance to help industry know when a microneedling product is legally considered a medical device subject to legal and regulatory requirements.
09/14/2017
 
 
TXT Drug/Biologic User Fees for FY 2018 [75 Words] [ Price : $8.95]
Federal Register notice: FDA announces the rates for prescription drug user fees for fiscal year 2018.
09/14/2017
 
 
TXT Biosimilar User Fee Rates for FY 2018 [79 Words] [ Price : $8.95]
Federal Register notice: FDA announces rates for biosimilar user fees for fiscal year 2018.
09/14/2017
 
 
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