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.
The Office for Human Research Protections (OHRP) released draft guidance on 1/10/2019 for public comment titled “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l)).” While the guidance is draft, it provides insight into OHRP’s...
NEWS FLASH: OHRP Notice of Availability (NOA) of a Draft Guidance Document Related to the Revised Common Rule Published in the Federal Register
The Office for Human Research Protections (OHRP) has published a draft guidance document to “help entities determine whether a planned activity constitutes a public health surveillance activity deemed not to be research under the 2018 Requirements” (i.e.,...