Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability

Resumo

Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the Food and Drug Administration (FDA or Agency) is required to report annually in the Federal Register on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct. A supplemental report containing additional information and analyses on the status of PMRs and PMCs is available on FDA's Web site.\1\ ---------------------------------------------------------------------------