Zdrowie i gospodarka · 28.03.1996
Changes to An Approved Application; Proposed Rule and Draft Guidance Documents; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed amendments to the biologics regulations for reporting changes to an approved application and corresponding drug regulations for submitting supplements for and reporting changes to an application for well-characterized biotechnology products. The purpose of the meeting is to solicit information and views on the agency's proposed rule addressing reporting of changes to an approved application as well as discuss the material and categories set forth in the closely related draft guidance documents.