Federal Register notice: FDA seeks comments on an information collection extension entitled Format and Content Requirements for Over-the-Counter Drug ...
Bottle of Lies author Katherine Eban says she finds it disturbing that FDA supervisors are downgrading the severity of foreign inspection findings and...
Five drug companies comment on an FDA draft guidance on bispecific antibody development.
FDA says it will use enforcement discretion to not act against certain food or dietary supplement health claims for omega-3 fatty acids.
FDA warns PRL, Inc., about CGMP and other violations in its production of dietary supplements.
FDA acting commissioner Ned Sharpless says the agency is enhancing the data in the generic drug Paragraph 4 patent certification list as part of an ef...
FDA grants Abeona Therapeutics a fast track designation for ABO-202, a novel one-time AAV9 gene therapy for CLN1 disease.
FDA clears a Life Spine 510(k) for the Prolift Lateral Expandable Spacer System for use in treating spinal disorders.