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TXT Mesoblast Rolling BLA Submission for Remestemcel-L [210 Words] [ Price : $8.95]
Mesoblast files as part of a rolling BLA clinical efficacy and safety data for remestemcel-L, indicated for treating children with steroid-refractory acute graft versus host disease.
01/02/2020
 
 
TXT FDA Drops Peptide Transition Exclusion [2809 Words] [ Price : $8.95]
FDA says that allowing chemically synthesized peptides to use the biosimilar or interchangeable approval pathway will benefit consumers by bringing follow-on insulins to market quicker.
01/02/2020
 
 
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 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FDA releases a draft guidance on “Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.”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 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Federal Register: FDA makes available a draft guidance entitled “FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs.”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 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
 
 
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