Zdrowie i gospodarka · 31/12/2002
FDA Publishes Draft Guidance on Periodic Safety Update Reports for Marketed Drugs
The FDA has released a draft guidance on Periodic Safety Update Reports (PSURs) for marketed drugs, an addendum to the 1997 ICH E2C guidance, to clarify the content and format of PSURs and harmonize the collection and submission of postmarketing clinical safety data.
Source: Federal Register — Food and Drug AdministrationOpen original release →