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TXT Industy Reps Sought for Mammography Panel [95 Words] [ Price : $8.95]
Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representatives to serve on CDRH’s National Mammography Quality Assurance Advisory Committee.
12/12/2019
 
 
TXT FDA Qualifies MRI Compatibility, Safety Software [2671 Words] [ Price : $8.95]
FDA qualifies the first computational modeling tool to be used with a wide range of implantable active medical devices through the Medical Device Development Tools program.
12/12/2019
 
 
TXT Seven Observations on Exela FDA-483 [2740 Words] [ Price : $8.95]
FDA releases an FDA-483 with seven observations from an inspection at the Exela Pharma Sciences outsourcing facility.
12/12/2019
 
 
TXT Webinar on FDA-3542 and FDA-3542a Updates [2633 Words] [ Price : $8.95]
A CDER Webinar explains updates to forms FDA-3542a and 3542 and instructs participants on how to complete the forms.
12/12/2019
 
 
TXT Draft Pediatric Oncology Studies Guidance [2788 Words] [ Price : $8.95]
FDA publishes for comment a draft guidance on early planning for pediatric evaluation of certain molecularly targeted oncology drugs.
12/12/2019
 
 
TXT Senate Confirms Hahn as Next FDA Commissioner [210 Words] [ Price : $8.95]
The Senate confirms Stephen Hahn as the next FDA commissioner on a floor vote of 72-18.
12/12/2019
 
 
TXT Newborn Test for Duchenne’s Cleared for Use [248 Words] [ Price : $8.95]
FDA authorizes the de novo marketing of PerkinElmer’s GSP Neonatal Creatine Kinase-MM kit as an aid in newborn screening for Duchenne Muscular Dystrophy.
12/12/2019
 
 
TXT Elite Pharmaceuticals ANDA for Generic Adderall XR [107 Words] [ Price : $8.95]
FDA approves an Elite Pharmaceuticals ANDA for a generic version of Shire’s Adderall XR, indicated for treating attention deficit hyperactivity disorder.
12/12/2019
 
 
TXT House Passes Drug Pricing Bill [3002 Words] [ Price : $8.95]
The House approves drug pricing legislation that is likely to die in the Senate or face a presidential veto.
12/12/2019
 
 
TXT Provention Bio Plans Rolling BLA for 2020 [2628 Words] [ Price : $8.95]
Provention Bio says it is planning a rolling BLA application for its Type 1 diabetes drug teplizumab in 2020.
12/12/2019
 
 
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