Recently Posted Guidance Documents
6/17/15: Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices - Guidance for Industry and Food and Drug Administration Staff
6/18/15: CVM GFI #187 Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs
6/18/15: Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff
6/18/15: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
6/18/15: CVM GFI #187 Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs
6/18/15: Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff
6/18/15: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
No hay comentarios:
Publicar un comentario