Federal Register notice: FDA corrects the docket number in a 9/7 Federal Register notice announcing a draft guidance entitled Policy Regarding Quantit...
Federal Register notice: FDA submits to OMB an information collection extension for Electronic User Fee Payment Request Forms Form FDA 3913 and Form ...
A June FDA inspection of drug supplier McKesson results in a three-item Form 483 citing deficiencies with product tracing requirements.
FDA clears an Applied BioCode 510(k) for its BioCode Gastrointestinal Pathogen Panel and its use with the high throughput BioCode MDx-3000 molecular s...
Washington Legal Foundation asks the Utah Supreme Court to recognize that implanted medical devices are unavoidably unsafe.
The Medical Device Innovation Consortium lists the many benefits arising from adoption of coordinated voluntary disclosure policies on cybersecurity b...
Federal Register notice: FDA extends the comment period for a draft guidance entitled Process To Request a Review of FDAs Decision Not To Issue Certai...
Federal Register notice: FDA seeks comments on an information collection extension entitled Investigational New Drug Application21 CFR Part 312.