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TXT Suit Seeks Info on Any Sharpless Drug Conflict [420 Words] [ Price : $8.95]
Watchdog group Restore Public Trust files suit to get FOI documents on whether FDA acting commissioner Ned Sharpless is asserting any influence at the agency to advance a drug being developed by a firm he cofounded.
08/09/2019
 
 
TXT Public Meeting Seeks Priorities for New Drug Review [230 Words] [ Price : $8.95]
FDA says it is planning an 11/7 public meeting to seek input on opportunities and priorities for CDER’s Office of New Drugs.
08/09/2019
 
 
TXT Kala Pharma Dry Eye NDA Rejected; More Data Needed [168 Words] [ Price : $8.95]
FDA issues Kala Pharmaceuticals a complete response letter on its NDA for KPI-121 (loteprednol etabonate) for dry eye disease signs and symptoms.
08/09/2019
 
 
TXT FDA Tests New BE Method for Generic Topicals [353 Words] [ Price : $8.95]
A new FDA Impact Story discusses new research undertaken to help would-be generic topical dermatological drug product developers demonstrate bioequivalence.
08/09/2019
 
 
TXT Ortho Dermatologics NDA Accepted for Acne Lotion [159 Words] [ Price : $8.95]
FDA accepts for review an Ortho Dermatologics NDA for tazarotene 0.045% lotion for treating moderate to severe acne.
08/09/2019
 
 
TXT Amarin Expects Review Extension on Vascepa sNDA [313 Words] [ Price : $8.95]
Amarin says FDA likely will extend its review of a supplemental NDA seeking an expanded indication for Vascepa (icosapent ethyl) capsules after revealing that it plans to hold an advisory committee meeting 11/14 on the submission.
08/09/2019
 
 
TXT Endologix Study for Aortic Aneurysms Device [202 Words] [ Price : $8.95]
FDA gives Endologix authorization to begin a pivotal study to evaluate the safety and effectiveness of its Nellix Chimney EndoVascular Aneurysm Sealing System.
08/09/2019
 
 
TXT AveXis Inspection Observations [2379 Words] [ Price : $8.95]
FDA releases the FDA-483 with five inspection observations issued following an inspection at the AveXis control testing laboratory.
08/08/2019
 
 
TXT CBER FY 2018 Product Deviation Reports [181 Words] [ Price : $8.95]
CBER releases its summary deviations report for FY 2018 covering biological products and HCT/Ps.
08/08/2019
 
 
TXT Panel Backs Descovy for Preventing HIV in Men [229 Words] [ Price : $8.95]
An FDA advisory committee has voted 16-2 to recommend approval for Gilead Sciences’ HIV drug Descovy for pre-exposure prophylaxis (PrEP) in men and transgender women, but not for cisgender women.
08/08/2019
 
 
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