Over the past year and a half, FDA has carefully inventoried its programs and identified issues to launch the HSP/BIMO Initiative. As this initiative moves forward, FDA will continue to gather additional issues for the initiative and related information from internal and external stakeholders, e.g., industry, academic, and government activities and programs, and intends to conduct workshops and create other opportunities for public input.

Janet Woodcock, M.D., Deputy Commissioner for Operations, will chair the HSP /BIMO steering committee which is comprised of representatives from the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Food, Safety, and Nutrition (CFSAN), Center for Veterinary Medicine ( CVM ), Office of Regulatory Affairs (ORA), and the Office of the Commissioner (OC).


Highlights of what has been completed to date include:

* Draft Guidance; Process for Handling Referrals to FDA Under 21 CFR 50.54; Additional Safeguards for Children in Clinical Investigations, published May 2006
* Guidance for Industry - Using a Centralized IRB Process in Multicenter Clinical Trials, published in March 2006
* Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees, published in March 2006
* Information Sheet Guidances for IRBs, Clinical Investigators, and Sponsors, five published in final January 2006

Projects in progress:

* Modernizing adverse event reporting to institutional review boards (IRBs) to accommodate major trend toward multicenter trials (March 2005, held Part 15 Hearing - Adverse Event Reporting to IRBs, currently working on draft guidance)
* Published proposed rule: Institutional Review Board - Registration Requirements, FDA reviewing comments
* Finalizing rule: Foreign Clinical Studies not Conducted Under an IND (21 CFR 312.120)


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The FDA will also consolidate safety reporting systems for drugs and medical devices, establishing a new electronic system to collect adverse events reports on both, according to an AP report.

Separate systems are now in use. At a health care conference in Washington, D.C., Scott Gottlieb, FDA deputy commissioner for scientific and medical affairs, said that the new system, which FDA hopes to establish within two years, would combine the current systems in a integrated electronic IT plan.

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