Five stakeholders raise substantive concerns about an FDA draft guidance on selecting, developing, or modifying fit-for-purpose clinical outcomes asse...
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Federal Register notice: FDA posts a draft guidance entitled Ethical Considerations for Clinical Investigations of Medical Products Involving Children...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...
