We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Nearly 70 percent of device manufacturers say the FDA’s Medical Device User Fee and Modernization Act of 2002 (MDUFMA) has not improved the predictability or timeliness of device reviews, according to a survey conducted by the Lewin Group for the FDA released April 26.
Boston Scientific received antitrust approval from the Federal Trade Commission (FTC) for its proposed merger with Guidant, Boston Scientific announced April 20.
Formalizing presubmission reviews of drug applications will improve the drug pipeline by cutting down on both regulatory and industry inefficiency, Andrew von Eschenbach, the agency’s acting commissioner, says.
After a four-year delay, researchers in India have received regulatory approval to restart the trial of a male contraceptive, reversible inhibition of sperm under guidance (RISUG) — a nonhormonal treatment that provides 10 or more years of protection after a 10- to 15-minute outpatient procedure.
Boston Scientific announced that it has made certain commitments to the European Commission (EC) as part the antitrust review of the’s company’s merger with Guidant.
Approval of over-the-counter (OTC) HIV test kits will depend on how they perform in the hands of untrained consumers, the FDA suggested in a summary delivered recently to its Blood Products Advisory Committee.