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Federal Register notice: FDA posts a draft guidance entitled Ethical Considerations for Clinical Investigations of Medical Product...[ Price : $8.95]
FDA concludes after ending a recent pilot program on software as a medical device that a new regulatory paradigm is needed to regu...[ Price : $8.95]
FDA posts three Form FDA-483s issued to Indias Biocon Biologics following three on-site August inspections at the companys seven m...[ Price : $8.95]
CDER Office of Generic Drugs director Sally Choe decides to leave FDA effective 10/8 to pursue opportunities outside the agency.[ Price : $8.95]
Former New York cannabis programs director Norman Birenbaum joins CDERs Office of the Center Director as a senior public health ad...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Exemption and Exclusion from Certain Requirements of the Dr...[ Price : $8.95]
Federal Register FDA determines for patent extension purposes the regulatory review period for Biohaven Pharmaceuticals migraine d...[ Price : $8.95]
Federal Register notice: FDA seeks comments on a new information collection involving a pediatric device survey.