Search Results for citation:"90 FR 15248"

The Food and Drug Administration (FDA) announced that ETHYOL (amifostine) for injection, 500 mg/vial, was not removed from the market due to safety or effectiveness issues. This ruling implies that the FDA will not take action to revoke approvals for generic versions of this drug and can continue approving such versions if they comply with legal standards. The determination follows a petition and a review of available data, with no evidence found suggesting safety problems. As such, ETHYOL will stay on the "Discontinued Drug Product List" for reasons unrelated to safety or effectiveness.

The Food and Drug Administration (FDA) is reopening the deadline for public comments on a draft guidance for industry titled "Type VII Veterinary Master File for Research and Development and Risk Reviews." Originally, comments were due by March 10, 2025, but the FDA has extended the period by 60 days, allowing comments to be submitted until June 9, 2025. This extension responds to a request for more time to provide thorough feedback before the FDA finalizes the guidance. Comments can be submitted electronically via regulations.gov or as paper submissions to the Dockets Management Staff in Rockville, MD.