In the industry's words
This article was originally published in RAJ Devices
On tenterhooks over the US Food and Drug Administration's reform of the 510(k) review process, the US medical technology industry is warning that the potential changes threaten its position as global leader in the supply of these products. Mark Leahey, president and CEO of the Medical Device Manufacturers Association, warns against any move that might lead to a major weakening of medtech innovation
You may also be interested in...
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.
Genfit will delay unblinding of data from its nearly complete Phase III study of elafibranor to get insight from the FDA on statistical methods in order to optimize its NDA.
Revolution has just one drug in the clinic, but its focus on KRAS excited IPO investors. Also, Deciphera’s $175m offering leads recent follow-ons and Spruce raises $88m in venture capital.