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Zdrowie i gospodarka · 5.01.2007

Supplements and Other Changes to an Approved Application; Public Meeting

The Food and Drug Administration (FDA) is announcing a public meeting to solicit comments on issues that FDA should consider when developing revisions to its regulations regarding chemistry, manufacturing, and controls (CMC) supplements and other changes to approved marketing applications for human drugs. FDA is evaluating how it could revise its regulations to allow for consideration of risk- based approaches based on manufacturing process understanding, including prior knowledge of similar products, and overall quality systems to provide an enhanced risk-based approach to the CMC regulatory process, which would reduce the number of supplements. We will consider the input from the public meeting and comments on the issues presented in this document as we consider whether to revise our regulations.

Source: Federal Register — Food and Drug AdministrationOpen original release →