Department of Health and Human Services August 2, 2024 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance for industry entitled "M12 Drug Interaction Studies" and the supplemental document entitled "M12 Drug Interaction Studies: Questions and Answers." The guidance and supplemental questions and answers document were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance provides general recommendations on evaluating the enzyme and transporter-mediated pharmacokinetic drug-drug interaction potential for investigational drugs. The supplemental questions and answers document provides clarity to some concepts related to evaluation of drug interactions covered in the guidance. The guidance is intended to harmonize the regional recommendations for designing, conducting, and interpreting in vitro and clinical evaluations of drug-drug interactions while developing investigational drugs. The guidance replaces the draft guidance "M12 Drug Interaction Studies" issued on August 29, 2022.

This notice announces the next meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM is a federally chartered external advisory group of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organizations. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM.

The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Psychopharmacologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Psychopharmacologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the June 4, 2026, expiration date.