The FY2025 FDA Report on the State of Pharmaceutical Quality shows increased quality assurance inspections over FY 2024.
A newly published commentary in the journal Stem Cell Research & Therapy says FDAs efforts to reduce reliance on animal testing is driving a fundament...
Two stakeholders ask for greater specificity in an FDA draft guidance on establishing impurity specifications for antibiotics.
Three stakeholders comment on an FDA request for information on AI-enabled optimization of early-stage clinical trials.
The Trump Administration considers White House health policy adviser Heidi Overton as a leading candidate to become the next FDA commissioner.
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 ...