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FDA posts details of an Accreditation Scheme for Conformity Assessment (ASCA) pilot program that aims to enhance the predictabilit...[ Price : $8.95]
An FDA analysis says more ANDAs could be approved in the first cycle if sponsors ensured their applications were complete at the t...[ Price : $8.95]
FDA medical reviewers raise questions about several aspects of an Alkermes NDA for a combination drug to treat major depressive di...[ Price : $8.95]
FDA commissioner Scott Gottlieb introduces a new Plant and Animal Biotechnology Innovation Action Plan to help ensure the safety o...[ Price : $8.95]
Due to supply shortage concerns, FDA allows two-month expiry date extensions on some epinephrine auto-injectors, 0.15 mg and 0.30 ...[ Price : $8.95]
Federal Register notice: FDA opens a public docket to receive suggestions and comments on the agencys publication of its surrogate...[ Price : $8.95]
Federal Register notice: FDAs chief scientist denies a request for a hearing on a CDER proposal to refuse approval of a Pharmaceut...[ Price : $8.95]
FDA releases its latest batch of Warning Letters that include Boule Medical, Cardiomed Supplies, Gaeltec Devices and Leventon.