Source: https://www.federalregister.gov/documents/2012/03/07/2012-5476/modernizing-the-regulation-of-clinical-trials-and-approaches-to-good-clinical-practice-public
Timestamp: 2020-02-21 10:54:37
Document Index: 152869987

Matched Legal Cases: ['§\u200915', 'art 15', 'art 10', 'art 10', '§\u200910', '§\u200915', 'art 15', '§\u200915']

Federal Register :: Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice; Public Hearing; Request for Comments
A Proposed Rule by the Food and Drug Administration on 03/07/2012
https://www.federalregister.gov/d/2012-5476 https://www.federalregister.gov/d/2012-5476
In 2004, FDA introduced the Critical Path Initiative (CPI),[1] intended to transform the way medical products are developed, evaluated, and manufactured. One of the CPI's key areas of focus is modernizing clinical trial sciences to make trials safer and more efficient. As part of this larger initiative, FDA launched two initiatives to specifically address human subject protection, data integrity, and clinical trial quality and efficiency.
In 2006, FDA launched the Human Subject Protection and Bioresearch Monitoring Initiative [2] aimed at modernizing and strengthening FDA's oversight and protection of human subjects and the integrity of data in clinical trials. FDA's Office of Good Clinical Practice in the Office of the Commissioner is leading this effort. FDA also established a Human Subject Protection and Bioresearch Monitoring Council that manages and sets FDA policy on bioresearch monitoring, GCP, and human subject protection.
In 2007, FDA and Duke University formed the Clinical Trials Transformation Initiative (CTTI),[3] a public-private partnership with the goal of improving the quality and efficiency of clinical trials. CTTI has been involved in a range of projects, including projects to identify best practices for monitoring and designing quality into clinical trials, improve serious adverse event reporting to investigators, and gather best practices for premarket safety surveillance.
In 2011, FDA published a Federal Register notice requesting comment on the development of a plan for the retrospective review of existing FDA regulations [4] in accordance with Executive Order 13563, “Improving Regulation and Regulatory Review.” As part of this plan, FDA is conducting a review of existing regulations to determine which, if any, of its rules are outmoded, ineffective, insufficient or excessively burdensome and may be good candidates to be modified, streamlined, expanded or repealed. The Agency is also evaluating its framework for periodically analyzing existing rules.[5]
FDA has also taken steps to improve its clinical trial inspection processes and coordinate inspection processes globally. Ongoing efforts are aimed at developing new approaches for selecting clinical investigator sites for inspection and for improving the warning letter process. FDA is also involved in a Good Clinical Practice Initiative [6] with the European Medicines Agency (EMA), in which FDA and the EMA have shared information on applications, collaborated on joint and observational inspections, participated in bilateral training, and kept each other informed of GCP-related legislation, regulatory guidance, and related documents. These steps have facilitated improvements in FDA's inspection coverage and decision-making processes.
Under § 15.30(f), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (part 10, subpart C (21 CFR part 10, subpart C)). Under § 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b) (see section VII of this document). To the extent that the conditions for the hearing, as described in this notice, conflict with any provisions set out in part 15, this notice acts as a waiver of those provisions as specified in § 15.30(h).