Comment from Mitchell Berger

Dear Dr. Honchel: In response to the above notice issued by CDER, I write to urge FDA to finalize the above-titled draft guidance. This guidance was initially issued in 2023 via the above Federal Register notice. Publication of the draft guidance was noted in the media and by those interested in FDA’s Animal Rule. However, FDA’s guidance materials and Web site reflect that a final document on developing drugs for acute radiation syndrome (ARS) has not yet been issued. As the docket for this guidance on Regulations.gov appears to be accepting late comments, I am adding this note in the hope that FDA staff will complete this important guidance. Even though draft guidance is important, a finalized guidance may reassure product sponsors and have heightened impact. Full comment is below. Sincerely, Mitchell Berger