Federal Register Final rule: FDA is amending its regulations describing postmarketing reporting requirements to require an applicant who is the sole manufacturer of drug products that are life supporting, life sustaining, or intended for use in preventing a serious disease or condition and that were not originally derived from human tissue and replaced by a recombinant product, to notify FDA at least six months before discontinuing manufacture of the drug product. This implements certain provisions of the Food and Drug Administration Modernization Act of 1997. To view this final rule, click here.