Release of the report, kicks off a new FDA-wide Innovation Initiative, which promises to redouble the agency’s efforts to encourage innovations that will promote public health as well as strengthen the American economy.
We are committed to continuing our dialogue with companies, innovators, patients, and other stakeholders to identify barriers to progress and better define what steps need to be taken to overcome any obstacles to innovation.
FDA Commissioner Margaret A. Hamburg, M.D., today released a blueprint containing immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans.
Titled “Driving Biomedical Innovation: Initiatives for Improving Products for Patients,”the blueprint addresses concerns about the sustainability of the medical product development pipeline, which is slowing down despite record investments in research and development.
“The Obama Administration is committed to encouraging the entrepreneurs and businesses that are modernizing and strengthening our health care system,” said HHS Secretary Kathleen Sebelius. “The innovation blueprint is another part of our effort to help businesses grow and keep Americans healthy.”
“America is at an important crossroads, where the science before us presents unprecedented opportunities to create new and better medical products and to promote better health for the public,” said Hamburg. “Our innovation blueprint highlights some of the initiatives FDA will be implementing to ensure that these opportunities are translated into safe and effective treatments that can help keep both American patients and American industry healthy and strong.”
While FDA has long been committed to promoting innovation with a number of efforts underway already this year, Dr. Hamburg recognized the need to create an FDA-wide framework to address the changing scientific landscape. This blueprint launches the Innovation Initiative, identifying additional steps the agency can take immediately to address the most pressing concerns facing patients and industry.
The report’s proposals stem from a review of FDA’s current policies and practices, as well as months of meetings with major stakeholders nationwide, including key industry leaders, small biotech, pharmaceutical and medical device company owners, members of the academic community, and patient groups.
The blueprint focuses on implementing the following major actions:
• rebuilding FDA’s small business outreach services
• building the infrastructure to drive and support personalized medicine
• creating a rapid drug development pathway for important targeted therapies
• harnessing the potential of data mining and information sharing while protecting patient privacy
• improving consistency and clarity in the medical device review process
• training the next generation of innovators
• streamlining and reforming FDA regulations.
The blueprint was released during the commissioner’s appearance at the 3rd annual Washington Ideas Forum, sponsored by The Atlantic magazine in partnership with the Aspen Institute and the Newseum.
FDA Commissioner Margaret A. Hamburg, M.D., today released a blueprint containing immediate steps that can be taken to drive biomedical innovation, while improving the health of Americans.
Titled “Driving Biomedical Innovation: Initiatives for Improving Products for Patients,”the blueprint addresses concerns about the sustainability of the medical product development pipeline, which is slowing down despite record investments in research and development.
“The Obama Administration is committed to encouraging the entrepreneurs and businesses that are modernizing and strengthening our health care system,” said HHS Secretary Kathleen Sebelius. “The innovation blueprint is another part of our effort to help businesses grow and keep Americans healthy.”
“America is at an important crossroads, where the science before us presents unprecedented opportunities to create new and better medical products and to promote better health for the public,” said Hamburg. “Our innovation blueprint highlights some of the initiatives FDA will be implementing to ensure that these opportunities are translated into safe and effective treatments that can help keep both American patients and American industry healthy and strong.”
While FDA has long been committed to promoting innovation with a number of efforts underway already this year, Dr. Hamburg recognized the need to create an FDA-wide framework to address the changing scientific landscape. This blueprint launches the Innovation Initiative, identifying additional steps the agency can take immediately to address the most pressing concerns facing patients and industry.
The report’s proposals stem from a review of FDA’s current policies and practices, as well as months of meetings with major stakeholders nationwide, including key industry leaders, small biotech, pharmaceutical and medical device company owners, members of the academic community, and patient groups.
The blueprint focuses on implementing the following major actions:
• rebuilding FDA’s small business outreach services
• building the infrastructure to drive and support personalized medicine
• creating a rapid drug development pathway for important targeted therapies
• harnessing the potential of data mining and information sharing while protecting patient privacy
• improving consistency and clarity in the medical device review process
• training the next generation of innovators
• streamlining and reforming FDA regulations.
The blueprint was released during the commissioner’s appearance at the 3rd annual Washington Ideas Forum, sponsored by The Atlantic magazine in partnership with the Aspen Institute and the Newseum.
- Printer Friendly PDF1 (6.3MB)
Contents: Browse the Biomedical Innovation Initiatives for Improving Patient Products
- A Note from the Commissioner4
- Overview5
- Rebuilding FDA’s Small Business Outreach Services8
- FDA Small Business Liaison Program9
- Young Entrepreneurs10
- Partnering with the Small Business Administration11
- Building the Infrastructure to Drive and Support Personalized Medicine12
- Scientific Leadership: Supporting Personalized Medicine through Regulatory Science13
- Regulatory Infrastructure: Facilitating Personalized Medicine through FDA Policies and Procedures14
- Deputy Commissioner for Medical Products15
- Expedited Drug Development Pathway16
- Harnessing the Potential of Data Mining and Information Sharing17
- Scientific Computing and the Science Enclaves at FDA18
- Modernizing the FDA IT Infrastructure to Support Scientific Computing19
- Building an Infrastructure for Patient-Centered Outcomes Research20
- Opportunities through Public-Private Partnerships21
- The Future of Medical Devices 22
- New Expedited Review Program23
- Understanding Emerging Technologies24
- Increasing Consistency through Improved Training25
- Providing Additional Clarity to Industry26
- Training the Next Generation of Innovators27
- Improving FDA Regulations28
- Conclusion29
White House Blog2- Innovation at the Food and Drug Administration
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