FDA Publishes Companion Proposed Rule to Repeal Antibiotic Drug Certification Regulations

Summary

The Food and Drug Administration (FDA) is publishing a proposed rule to repeal its regulations governing the certification of antibiotic drugs, in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA). This action is intended to align with the provisions of FDAMA, which repealed the statutory provision under the Federal Food, Drug, and Cosmetic Act (FDCA) that allowed the agency to certify antibiotic drugs.