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Angie Drakulich was editorial director of Pharmaceutical Technology.
The US Food and Drug Administration has released an implementation report on its Regulatory Science Initiative. The report outlines the agency's plans to advance regulatory science through new tools, standards, and approaches for assessing the safety, efficacy, quality and performance of FDA-regulated products, according to an agency press release.
The US Food and Drug Administration released an implementation report on its Regulatory Science Initiative. The report outlines the agency’s plans to advance regulatory science through new tools, standards, and approaches for assessing the safety, efficacy, quality, and performance of FDA-regulated products, according to an agency press release.
Last February, FDA launched the Regulatory Science Initiative to fast-track drug product innovations to the public. The strategy builds upon the agency’s Critical Path Initiative (See back story, “FDA and NIH Collaborate to Speed the Introduction of New Medicines”).
Included in the new report are examples of FDA activities in regulatory science as well as recommendations for helping to deliver better and safer products to the market. The following seven public-health areas are addressed:
For scientific advances to reach their full potential, FDA “must play an increasingly integral role as an agency not just dedicated to ensuring safe and effective products, but also to promote public health and participate more actively in the scientific-research enterprise directed towards new treatments and interventions,” according to the report’s executive summary. “We must also modernize our evaluation and approval processes to ensure that innovative products reach the patients who need them, when they need them.”
The initiative, based on President Obama’s $25-million budget request for fiscal year 2011, includes a new office of regulatory science within FDA, and focuses on the following:
In FY2011, according to the report, the agency will support research in transforming product development for patients(e.g., methods for modernizing toxicology, biomarkers, stem-cell initiatives, and drug-review standard updates), science to address emerging technologies in FDA-regulated products (e.g., nanotechnology and new animal biotechnology products), information sciences for health outcomes (e.g., a medical device registry), addressing unmet public health needs
FY2011 activities will also work toward the opening of a network of Centers of Excellence in Regulatory Science “to be integrated with expanded intramural FDA research and with other clinical research networks,” says the summary.
FDA Commissioner Margaret Hamburg discussed the initiative at the National Press Club last week.