The Association of Health Care Journalists urges its journalist members to look deeper into FDAs use of advisory committees in its regulatory decision...
Federal Register final rule: FDA amends the color additive regulations to allow calcium carbonates use in dietary supplement tablets and capsules.
Federal Register notice: FDA posts a draft guidance entitled Ethical Considerations for Clinical Investigations of Medical Products Involving Children...
FDA concludes after ending a recent pilot program on software as a medical device that a new regulatory paradigm is needed to regulate such devices.
FDA posts three Form FDA-483s issued to Indias Biocon Biologics following three on-site August inspections at the companys seven manufacturing sites i...
CDER Office of Generic Drugs director Sally Choe decides to leave FDA effective 10/8 to pursue opportunities outside the agency.
Former New York cannabis programs director Norman Birenbaum joins CDERs Office of the Center Director as a senior public health advisor on cannabis is...
Federal Register notice: FDA makes available a final guidance entitled Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Secu...
