TAG ARCHIVES FOR FDA

18
Aug2022

While the FDA and OHRP share a mission in protecting volunteers in research, the FDA has a unique responsibility as a public health and consumer protection agency. The dual mission is reflected in the purpose for Investigational New Drug and Investigational Device Exemption regulations which propose to assure safety and rights of subjects, permit evaluation of a drug’s safety and effectiveness, and encourage discovery and development of useful devices intended for human use.  Read more

9
Jun2022

On April 14, 2022, the FDA released draft guidance that aims to diversify the population of participants in clinical trials. Because the guidance is a draft, its content is open for public discussion and comment. Earlier this week, PRIM&R submitted comment to the FDA explaining how the guidance, while welcome, might be improved. Comments are due June 13, 2022, and we encourage others to submit their own comments (and feel free to borrow from ours)! Read more

21
Apr2022

In the not-so-distant past, IRBs reviewing artificial intelligence and machine learning protocols were quick to give not-human subject research determinations because the application was presented as a software development project. More recently, many IRBs improperly issue exempt determinations because the application is presented as a secondary-use data project. Read more

29
Mar2022

Have you ever heard the phrase "proper preparation prevents poor performance?" That refrain echoed in my mind as I enjoyed three AER21 sessions on implementing OHRP and FDA regulations. In each session, the presenters dismantled any fear I had surrounding interaction with regulatory entities by offering rubber-meets-the-road application of regulatory requirements and resources to be properly prepared. Read more

1
Mar2022

On Tuesday, February 15, Robert Califf, PhD, was confirmed by the US Senate to the position of commissioner of the Food And Drug Administration by a vote of 50-46. Dr. Califf’s nomination and appointment was unusually contentious, as key stakeholders from both major US political parties withheld votes to confirm the prominent cardiologist and clinical trial specialist. In 2017, Dr. Califf gave a keynote address at PRIM&R’s Advancing Ethical Research Conference called “The Continuum from Truth and Knowledge Generation to Opinion to False Information: Do We Have the Right Balance?” Read more