JAMA publishes a controversial Covid-19 vaccine effectiveness study, which was previously blocked from publication in a Centers for Disease Control an...
Eight Hyman, Phelps & McNamara attorneys analyze a House Appropriations Committee report that explains its rationale and expectations for the FY 2027 ...
The Federal Trade Commission files an amicus brief supporting plaintiffs in an antitrust lawsuit accusing Johnson & Johnson of unlawfully maintaining ...
A new CDER Office of New Drugs webinar discusses the development and use of OND Custom Medical Queries to identify potential safety signals during rev...
Harmed Americans for Reform in Medical Device Safety petitions FDA to require an IDE for the Vena MicroAngioscope and take other steps to determine if...
FDA warns South Koreas Huons Co. about CGMP violations in its manufacturing of finished drugs.
A Skadden Insights post raises the concern of FDA-regulated companies caused by the significant leadership changes at the agency.
FDA issues an early alert warning healthcare providers about a potentially high-risk device issue involving introducer kits used with Impella heart pu...
