Federal Register notice: FDA makes available a draft guidance entitled Definitions of Suspect Product and Illegitimate Product for Verification Obliga...
Federal Register notice: FDA seeks comments on post-marketing pediatric-focused safety reviews of products posted between 10/23/2017 and 3/16 on its W...
An FDA review of cancer drugs that used the accelerated approval program finds that very few of the resulting indications failed to verify clinical be...
CDER promotes Office of Strategic Programs director Theresa Mullin to a new position in Center director Janet Woodcocks immediate office associate di...
FDA Review posts the latest Federal Register notices for the week ending 3/2/2018.
FDA clears Coronary Systems 1.00mm Sapphire coronary balloon.
Opposed by womens health advocacy group National Center for Health Research, medical device industrys AdvaMed supports a CDRH and CBER proposal on a V...
FDA issues a safety alert about unapproved products claiming to prevent, treat or cure influenza.