FDA issues a final guidance on Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.
FDA Review posts the Federal Register notices for the week ending 9/8/2017.
FDA clears a Spinal Resources 510(k) for its Swedge Pedicle Screw System.
FDA issues Novartis a priority review voucher after approving qualifying rare disease product Kymriah (tisagenlecleucel).
Federal Register multiple notices: FDA seeks comments to help it identify existing regulations and related paperwork requirements that could be modifi...
The House and Senate approve a bill that provides funding for FDA and other government agencies until 12/8, as well as emergency disaster funding for ...
Federal Register notice: FDA announces a 1/11/2018 public workshop entitled Self-Collection Devices for Pap Test that will obtain feedback about self-...
A new study in The BMJ finds an association between expedited drug development and review pathways and the likelihood of subsequent safety-related lab...