RAPS

FDA clarifies reporting post-approval changes for disposable manufacturing materials

The US Food and Drug Administration (FDA) on Friday issued a question-and-answer guidance to provide clarity to manufacturers on reporting post-approval changes to disposable manufacturing material.
Health AffairsOpinion

Refining FDA’s Plausible Mechanism Framework, Part 2: Manufacturing Challenges, Product Scope, And Post-Approval Considerations

This is part two of a two-part article offering proposals to improve the FDA’s draft guidance to implement a new approval ...
RAPS

Industry pushes FDA for tailored complex generics post-approval changes guidance

The US Food and Drug Administration (FDA) needs to develop guidance on post-approval changes for complex generics, and to update its guidance on post-approval changes for non-complex generics as ...
JD Supra

Regulatory Overview: Post-Approval Changes to Marketed Drugs

The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently, the FDA approved Wegovy in tablet form, offering an alternative to the injection ...
Health Affairs

The FDA Amendments Act And Drug Safety: Where Are We Twenty Years Later?

Nearly two decades ago, Congress passed the US Food and Drug Administration (FDA) Amendments Act of 2007 , partially in ...