Improving FDA Regulations
In addition to developing new programs to adapt to the changing scientific landscape and ensure the safety, efficacy, and timely approval of new treatments and therapies for patients, FDA is also taking proactive steps to reform its existing regulations. Early this year, President Obama issued Executive Order (EO) 13563, outlining his plan for creating a 21st-century regulatory system that is simpler and smarter and that protects the health and safety of the American people in a pragmatic and cost-effective way. One goal of EO 13563 is to target existing rules to increase flexibility and remove regulations that are outdated, unnecessary, excessively burdensome, inefficient, or in conflict with other rules. Based on feedback from our partners in industry and academia and other stakeholders, and under the direction of the Commissioner, the Agency is currently reviewing its regulations to identify burdensome, unclear, obsolete, ineffective, or inefficient regulations. View a list of regulations already under review at FDA. The Agency also issued a Federal Register notice in April 2011 soliciting stakeholder input on additional rules that could be improved.
In addition, FDA has been revising rules to spur innovation and access to care as result of its existing retrospective review activities. For example, earlier this year, the Agency issued a final rule modernizing the requirements for constituent materials in biological products and has just proposed a rule to update and make more flexible the sterility test requirement for biological products. The proposed rule will allow greater innovation by industry to identify more rapid and sensitive means to evaluate biological products for sterility that may save both time and cost in lot release testing.