HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US TELL FRIEND RSS
 
Welcome to FDAweb
Pay Per View
Search our 66,082 - story database FREE
 
Free Items
 Warning Letters
 FDA Notices
 FDA Calendar
 

 FDA Whistleblowers



    








 
 
<< Prev  3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 Next >>
 
TXT Amarin Gains Expanded Use for Vascepa [1325 Words] [ Price : $8.95]
FDA approves the expanded use of Amarin’s Vascepa’s (icosapent ethyl) to reduce the risk of cardiovascular events as an adjunct to statin therapy in adults with elevated triglycerides and other cardiovascular disease risk factors.
12/13/2019
 
 
TXT Final Rule on Device e-Submissions [86 Words] [ Price : $8.95]
Federal Register notice: FDA issues a final rule amending requirements for medical device premarket submissions to require a single submission in electronic format.
12/13/2019
 
 
TXT Draft Guide on Pediatric Oncology Drugs [159 Words] [ Price : $8.95]
Federal Register: FDA makes available a draft guidance entitled “FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs.”
12/13/2019
 
 
TXT De Novo Authorization for Glycemic Controller [321 Words] [ Price : $8.95]
FDA authorizes the de novo marketing of Tandem Diabetes Care’s Control-IQ Technology, an interoperable automated glycemic controller device that adjusts insulin delivery by connecting to an alternate controller-enabled insulin pump and integrated continuous glucose monitor.
12/13/2019
 
 
TXT Irradiation Regulation Repeal to Help OTC Drugs [115 Words] [ Price : $8.95]
Federal Register notice: FDA issues a final rule to repeal a regulation that required an FDA-approved NDA or ANDA for any drug product that is sterilized by irradiation.
12/13/2019
 
 
TXT Boston Scientific Disposable Duodenoscope Cleared [163 Words] [ Price : $8.95]
FDA clears a Boston Scientific 510(k) for its Exalt Model D Single-Use Duodenoscope.
12/13/2019
 
 
TXT Draft Guide on Drug Development Tools Qualification [116 Words] [ Price : $8.95]
FDA releases a draft guidance on “Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.”
12/13/2019
 
 
TXT Futura to Seek FDA Placebo Pathway for ED [226 Words] [ Price : $8.95]
Futura Medical says it intends to discuss with FDA a medical device regulatory approval pathway for the placebo arm from an erectile dysfunction Phase 3 study after it outperformed the active study drug, MED2005 (nitroglycerine) gel.
12/12/2019
 
 
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
 
 
<< Prev  3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22  Next >>
 

FERDIC INCORPORATED - P.O. Box 28, Camp Hill, PA 17001 | Phone: (717)731-1426 fax:(717)731-1427 Email: info@fdaweb.com