FDA updates a Class 1 recall (correction) of Megadyne Medical Products Mega Soft patient return electrode models to reiterate the devices should not b...
FDA posts a draft guidance on Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institution...
Federal Register notice: FDA makes available a final guidance entitled Clinical Pharmacology Considerations for Antibody-Drug Conjugates.
Federal Register: FDA announces a publication containing modifications the agency is making to the list of standards it recognizes for use in premarke...
FDA grants full approval to Johnson & Johnsons Rybrevant (amivantamab-vmjw) in combination with chemotherapy for the first-line treatment of certain p...
CDRHs Binita Ashar says a recent journal article on breast implant risk provided useful information for patients and providers about the need for caut...
FDA publishes a guidance to assist in the development of antibody-drug conjugates with a cytotoxic small-molecule drug or payload.
FDA commissioner Robert Califf says it is very difficult for states to meet the standards set by Congress for importing drugs from Canada.
