(AGENPARL) – SILVER SPRING mar 11 aprile 2023 Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions Fonte/Source:…
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(AGENPARL) – CAMERINO (MC) mar 11 aprile 2023 Biological Assays for Structural-Activity Relationships and Drug Discovery Study Data evento 13/04/2023…
(AGENPARL) – WASHINGTON mar 11 aprile 2023 Content Files PDFXMLTEXTMetadata download Descriptive Metadata (MODS)Preservation Metadata (PREMIS)All Content and Metadata files,…
(AGENPARL) – NEW HAVEN, CONNECTICUT (USA) mar 11 aprile 2023 A new Yale study brings a game-changing insight to our understanding…
(AGENPARL) – SILVER SPRING lun 10 aprile 2023 Remarks by Robert M. Califf, M.D. Commissioner of Food and Drugs 2023 Rx…
(AGENPARL) – SILVER SPRING lun 10 aprile 2023 The OCE PFDD program fosters collaboration between FDA centers and external stakeholders involved…
(AGENPARL) – SILVER SPRING lun 10 aprile 2023 Audio Transcript | The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development Fonte/Source:…
(AGENPARL) – SILVER SPRING lun 10 aprile 2023 The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development Fonte/Source: http://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/role-pharmacodynamic-biomarkers-biosimilar-drug-development
(AGENPARL) – SILVER SPRING lun 10 aprile 2023 The list is updated quarterly. Changes are made to the DMF activity status, DMF…
(AGENPARL) – SILVER SPRING ven 07 aprile 2023 links to Drug Safety and Availability information Fonte/Source: http://www.fda.gov/drugs/drug-safety-and-availability