Federal Register notice: FDA makes available a final guidance entitled Recommendations for Dual 510(k) and CLIA Waiver by Application Studies.
Federal Register notice: FDA makes available a draft guidance entitled Product Labeling for Laparoscopic Power Morcellators.
Federal Register notice: FDA makes available a final guidance entitled Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) W...
CDRH launches a pilot of its new eSTAR platform for 510(k) submissions.
FDA releases the FDA-483 with four observations from an inspection at Dynalabs.
Two months ahead of its user fee review goal, FDA approves Puma Biotechnologys Nerlynx (neratinib) in combination with capecitabine for certain adult ...
FDA commissioner Stephen Hahn says FDA is using the best available science to evaluate possible non-drug regulatory pathways for CBD products.
Vizient says a consequence of FDA approval of four drugs under its Unapproved Drugs Initiative is an increase in health system spending of more than $...