Federal Register notice: FDA announces its intent to exempt certain subtypes of surgical apparel from premarket notification requirements, subject to ...
A federal judge sentences a Corpus Christi, TX, man to 12 months in prison for selling online and in stores dietary supplements that contained misbran...
The Center for Responsible Science asks a federal court to order FDA to grant its 2014 petition seeking improvements in clinical trial human subject p...
Paragon Consulting says businesses that invest now in a quality approach that fits with the FDA Quality Metrics Initiative can reap business as well a...
A CDRH Webinar describes elements in one final guidance and one draft guidance relating to the de novo classification program.
FDA commissioner Scott Gottlieb assures Congress that the timely implementation of the 21st Century Cures Act is one of the agencys highest priorities...
A PhRMA report traces how money moves through the pharmaceutical distribution system and suggests that patients should get more of the benefits from n...
Federal Register notice: FDA makes available a draft guidance entitled Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments ...