Stakeholders raise varying issues on an FDA draft guidance on submitting a 510(k) for medical device software changes.
Novartis files a supplemental BLA for Kymriah (tisagenlecleucel) suspension for intravenous infusion for treating adult patients with relapsed or refr...
A Massachusetts federal judge signs a consent decree barring Philips North America from manufacturing automatic external defibrillators at two plants ...
Federal Register notice: FDA makes available an International Council for Harmonization draft guidance entitled E9 (R1) Statistical Principles for Cli...
Federal Register notice: FDA announces a 12/11-12 public workshop on Packaging, Storage, and Disposal Options To Enhance Opioid Safety Exploring the ...
FDA denies an Empire State Consumer Project petition asking that it test PEG 3350 products for selenium and recall any such products containing seleni...
FDA denies a Pharmaceutical Manufacturing Research Services petition seeking a stay in the effective date of agency approval of Inspirons Roxybond imm...
Federal Register notice: FDA seeks comments on an information collection extension on the Guidance for Industry on Postmarketing Adverse Event Reporti...