The Food and Drug Administration (FDA) is reopening the period during which the public can submit comments on the document titled "Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products." Originally published on July 25, 2024, this reopening allows for updated or new information to be submitted, with a final deadline for comments set for March 3, 2025. Comments can be submitted electronically online or in written form to the FDA's Dockets Management Staff. Submissions must include the specific docket number and any confidential information must be clearly marked and handled as per FDA guidelines.
Simple Explanation
The FDA is asking people to share their thoughts again on a document about safety concerns with certain types of medicine-making proteins, so everyone has more time to say what they think before March 3, 2025.