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.
Theradaptive hopes to “change the practice of medicine by enabling precise tissue regeneration in a way that was not previously possible,” a company spokesperson said. Read More
The United Kingdom is reinventing its medical device regulatory framework now that it’s no longer in the European Union, and the country’s Medicines and Healthcare products Regulatory Agency (MHRA) is asking for public comment on “possible changes to the regulatory framework” for devices. Read More
A device manufacturer that undergoes an FDA inspection and gets a Form 483 with findings may avert a warning letter from the agency if it “really responds well,” said Jodi Scott, a partner at Hogan Lovells US, speaking Wednesday at the WCG and FDAnews-sponsored FDA Inspections vSummit. Read More
A federal judge has cleared Pfizer’s $345 million settlement resolving claims the drugmaker overcharged for its EpiPen epinephrine self-injector for treatment of severe allergic reactions. Read More