A CDRH report says there is improved medical device manufacturer compliance as a result of increased inspection oversight using a risk-based approach ...
Mylan says it is addressing an FDA Warning Letter about its Morgantown, WV, drug manufacturing plant in the context of a comprehensive restructuring a...
Some stakeholders fault FDA for issuing a draft guidance on product identifiers under the Drug Supply Chain Security Act just months before the end of...
Federal Register notice: FDA submits to OMB an information collection extension entitled Requirements on Content and Format of Labeling for Human Pres...
FDA accepts for priority review a Daiichi Sankyo NDA for quizartinib for treating adult patients with relapsed/refractory FLT3-ITD acute myeloid leuke...
FDA says Mylan has recalled 15 lots of valsartan-containing drugs that tested positive for NDEA above acceptable levels.
FDA grants OBI Pharma an Orphan Drug Designation for OBI-888 for treating pancreatic cancer.
The FDA Webview newsroom is closed in observance of the U.S. Thanksgiving Day holiday -- reopens Monday, November 26.