CDER Division of Biometrics IV director Dionne Price outlines ways in which FDA will promote use of complex innovative trial designs.
FDA releases its latest batch of Warning Letters that includes one medical product company Wilson Medicine Co.
Federal Register notice: FDA reopens the comment the comment period provided in a 2/16 notice entitled Pediatric Medical Device Development; Public Me...
FDA issues three guidances relating to insanitary conditions at drug compounding facilities and to repackaging or compounding of radiopharmaceuticals.
Federal Register notice: FDA announces the fee rate for using a tropical disease priority review voucher for fiscal year 2019 $2.46 million.
Federal Register notice: FDA issues a proposed order to reclassify the ultrasound cyclodestructive device, a postamendments Class 3 device into Class ...
FDA lifts a clinical hold against Sarepta Therapeutics against the companys Duchenne muscular dystrophy micro-dystrophin gene therapy program.
FDA approves Cook Medicals new 5 mm diameter version of Zilver PTX, the first 5 mm peripheral artery disease drug-eluting stent in the U.S. with lengt...