HRP Services
Interactions with Federal Agencies
Any program can find itself struggling with a regulatory interpretation or needing to report or respond to a federal agency. The best administrators realize that proactively addressing questions, managing mandated reporting responsibilities, and providing complete and on-target responses to findings or observations from federal agencies will minimize organizational risk and ensure that the credibility of their program remains intact.
With over 100 years of combined experience in the field, including experience within FDA, OHRP, and other agencies, our consultants and associates understand agency processes and expectations and can help your organization with anything from asking a question anonymously to responding to agency concerns and findings.
OHRP Issues Single IRB Draft Guidance
On July 1, 2022, OHRP posted a draft guidance document for public comment entitled “Use of a Single Institutional Review Board for Cooperative Research.” The draft guidance will be open for public comment until August 30, 2022. The recently posted draft guidance...
IND Safety Reports and IRBs
HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”:...