Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
FDA and OHRP Issue Joint Guidance on Minutes of IRB Meetings
The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have issued guidance titled, “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs”. This guidance was prepared jointly by FDA and OHRP and is intended for institutions and IRBs responsible for oversight of human subject research under FDA and HHS regulations.
To enhance human subject protection and reduce regulatory burden, OHRP and FDA have been actively working to harmonize the Agencies’ regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts. In addition, on December 13, 2016, the 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was signed into law. Title III, section 3023 of the Cures Act requires the Secretary of HHS to harmonize differences between the HHS human subject regulations and FDA’s human subject regulations. This guidance document is consistent with the goals of section 3023 of the Cures Act.
The purpose of the guidance is to assist institutions and IRBs in preparing and maintaining minutes of IRB meetings that meet the regulatory requirements for minutes set forth in FDA and HHS regulations. The guidance also provides general recommendations on the type and amount of information to be included in the minutes.