WASHINGTON, March 3 -- Food and Drug Administration has issued a notice called: Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments.
The notice was published in the Federal Register on March 3 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA, the Agency, or we) is announcing the opening of a public docket to solicit information and comments on the Agency's series of guidances for industry on scale-up and postapproval changes (SUPAC) for specific dosage forms. Specifically, we are seeking comment on the following guidances for industry: "Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval C...