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Federal Register Notice: FDA releases a second edition of the guidance entitled Demonstrating the Substantial Equivalence of a New...[ Price : $8.95]
Stakeholders ask for clarifications and editorial changes in an FDA draft guidance on assessing radiofrequency-induced heating.[ Price : $8.95]
FDA says Troy Innovative Instruments needs to retain an outside expert to audit and certify the firms compliance with the Quality ...[ Price : $8.95]
Reed Smith attorney James Beck criticizes as jurisfiction a Connecticut federal court ruling granting deference to FDA Warning Let...[ Price : $8.95]
Former FDA Office of Policy senior advisor Lisa Dwyer joins King & Spalding as a partner.[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Apis Vida Industria, Cellestis, GiaLive, and Troy Innovative Instruments.[ Price : $8.95]
Federal Register Notice: FDA seeks comments on an agency collection of information: Environmental Impact Considerations.[ Price : $8.95]
FDA announces a public workshop on Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants."