Additional OCP activities and impacts in FY 2008 are as follows:
- Advanced FDA’s Critical Path to New Medical Products Initiative:
- OCP continued to be active in interagency pharmacogenomics issues. OCP assisted in defining the regulatory path for novel technology diagnostics and biomarkers under review for use with drug or biological products.
- OCP continued to participate in the Interagency Task Force on Nanotechnology. FDA expects that many future nanotechnology products will be combination products. OCP continues to provide assistance in development of policy for these innovative products through the Nanotechnology Task Force and other nanotechnology-related activities. Specifically, OCP staff participated in a public-private workshop on research needs for nanotechnology. OCP also assisted in the planning of and participated in a September 2008 public meeting on nanotechnology.
- OCP continued to participate in the Interagency Working Group on the Artificial Pancreas. Specifically, OCP attended an Artificial Pancreas Public Workshop conducted with the National Institutes of Health in July 2008.
- Conducted nine presentations to external stakeholders and two presentations to FDA staff for education and training purposes, and conducted a variety of other outreach activities. Stakeholder presentations focused on the assignment and regulation of combination products; product development strategies; cGMP requirements; postmarket safety reporting requirements; and marketing application considerations, as well as discussion of OCP activities, initiatives, proposed regulations, and guidance. OCP presented and participated at the following meetings:
- 11th Conference of the Global Harmonization Task Force, October 2007
- Nanotechnology Law and Commerce: Business at One-Billionth of a Meter Forum, January 2008
- 32nd Good Manufacturing Practices Conference, University of Georgia, March 2008
- Association of Medical Diagnostics Manufacturers 510(k)/CDRH Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Workshop, April 2008
- Advanced Medical Technology Association (AdvaMed) Combination Products Training Session, May 2008
- Association of Food and Drug Officials Educational Conference, June 2008
- Regulatory Affairs Professionals Conference, September 2008
- BIOMEDevice Forum, September 2008
- College of Pharmacy, University of Georgia, September 2008
Internal presentations or meeting discussions focused on raising awareness of combination product issues, including the intercenter consultation process; the identification and categorization of combination product applications; jurisdiction issues; impact of developing new technologies; nanotechnology; cGMPs for combination products; and adverse event issues relating to combination products. OCP posts many of its presentations on the OCP Web site.
- OCP continued to obtain input from internal and external stakeholders:
- Met with trade associations and coalitions representing the drug, device, biological product, and combination product industries. Discussions focused on emerging issues in combination product regulation; the role of OCP; policies and guidances under consideration; monitoring intercenter consults; PMOA; cross-labeling of combination products; streamlining cGMP regulations and requirements; adverse event reporting; clarifying the number of marketing applications for combination products; and future industry needs in focused areas, such as, medical imaging, diabetes, diagnostic products, and novel technologies.
- Conducted periodic meetings with CBER, CDER, CDRH, and OC senior executive management. These meetings focused on key areas of combination product regulation and provided opportunities to discuss and help ensure support for OCP activities and initiatives.
- Responded to external and internal inquiries for reviews of journal articles, manuscripts, and presentations concerning combination product regulation and OCP roles and responsibilities. Reviewed and provided input for articles, reports, and presentations about the regulation of combination products and related issues regarding nanotechnology.
- Responded to requests for interviews and comments concerning combination product regulation and OCP roles and responsibilities. Responded to media inquiries seeking information about various aspects of how combination products are regulated and other related issues.
- Actively participated in the advancement of FDA Bioinformatics Initiatives and in the development of rules on drug and device registration and listing. OCP actively participated in three FDA-wide Commissioner-level business review boards with the goal of enhancing the electronic infrastructure necessary to facilitate the safety and effectiveness of combination products. Specifically, these activities are to promote the system design for postmarket adverse event safety reporting, consistency of electronic regulatory submissions pertaining to combination products, and the infrastructure for ensuring product quality and appropriate registration and listing. OCP also actively participated in work to develop a final rule for drugs and a proposed rule for devices relating to establishment of registration and product listing.
- Global Harmonization Task Force (GHTF) Activities: Participated as part of a panel on international regulatory issues at the GHTF Annual Meeting held October 2007. Also throughout the year, OCP facilitated development of FDA responses to the GHTF Steering Committee Ad Hoc Group on Combination Products.
- Participated and contributed to the FDA-wide initiative to redesign the FDA’s Internet and Intranet sites. Effective communication between FDA and the public is a necessary part of FDA’s mission as a regulatory agency. To better provide the public with up-to-date and easily accessible information, FDA is currently reviewing, reorganizing, and modernizing the content and design of FDA.gov, FDA’s Internet Web site. FDA has also undertaken a redesign of the internal FDA Intranet site. OCP participated as part of intercenter working groups by providing advice and guidance for the OCP portion of the redesigned Web sites.
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