As part of work under two executive orders, FDA centers on Thursday sought comments on which existing regulations and related paperwork requirements could be modified, repealed or replaced, to reduce the burden on industry while allowing the regulator to continue its public health mission while fulfilling statutory obligations.
Back in February, when President Donald Trump first announced his order to reduce regulatory burdens, several experts pointed Focus to some outdated regulations that could be removed with little impact on public health and the agency’s mission, though there are still questions as to what types of regulations will be targeted.
And as Anna Abram, FDA’s deputy commissioner for policy, planning, legislation and analysis, noted in a blog post on Thursday, there’s “a lot of ground to cover” as FDA’s regulations comprise more than 4,000 pages in the Code of Federal Regulations.
In general, though, the agency says it’s looking for comment and supporting technical, scientific, economic or other data from those significantly affected by FDA regulations, including consumers, patients and caregivers, researchers, healthcare institutions, the regulated industry, trade associations, public interest organizations, academia, and state, local and tribal governments.
“Some regulations may not adequately reflect advances in science, technology or changes in industry practice. Others may be geared toward products and practices that have largely ceased to exist,” Abram said, offering the example of how the manipulation of FDA’s rules on Risk Evaluation and Mitigation Strategies (REMS) can create obstacles to the timely entry of generic competition.
Featured in Thursday’s Federal Register notices are questions FDA says it is using to guide its initial review, including:
Image: Getty, Endpoints News, The White House
First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email email@example.com for more information.
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