TAG ARCHIVES FOR FDA

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

18
Sep2019

The International Conference of Harmonization (ICH), which is made up of the regulatory bodies and pharmaceutical trade associations of key drug developing countries, recently released their  revised “E8(R1) General Considerations for Clinical Studies” document. On September 16, PRIM&R submitted comments approving of ICH’s work to modernize their guidelines and suggesting that the document could benefit from a better discussion of the broad ethical principles that underlie many of the human subject protections the document details. We also recommend that the ICH consider reorganizing some of its guidelines to make it easier for those designing and conducting research to learn more about these fundamental ethical principles and related best practices. If you are based in the United States, we encourage you to consider submitting your own comments on the newly revised E8 document before the September 30 deadline. You are welcome to cite or quote PRIM&R’s comments. Read more