Author: Pinky Mazumder

On September 8th, 2017, the Food and Drug Administration signaled the start of a major regulatory overhaul by publishing a docket in the Federal Register (the “Docket”) requesting input from interested parties regarding unnecessary regulatory burdens (1). This move by the FDA is part of the Trump Administration’s well-publicized promise to cut regulations as enshrined in two Executive Orders published earlier this year.    

The Docket requests submissions from any interested person, including those subject to the agency’s regulations (i.e., pharmaceutical, medical device manufacturers), as well as academia, researchers, consumers, healthcare institutions, and patients. The Docket requests submissions regarding regulations which are no longer appropriate or have been superseded. As well, the agency invites comments regarding regulations that are difficult to comply with and pose an unnecessary regulatory burden. Submissions may be provided electronically or in hard-copy and should be submitted on or before December 7th, 2017 (1).

In addition to the revision of existing regulations and requirements, the FDA is also considering new regulations and policies to better fulfill its mission in public health (2). With advancing technologies, the agency wishes to establish regulations that are also appropriate for modern products (2). With this the FDA is reforming their regulatory framework to reduce regulatory burden to better serve public health.

Thank you for reading Regulated Affairs, the CAPRA Blog. CAPRA is a non-profit organization dedicated to providing professional development opportunities in Regulatory Affairs. Feel free to share our blog posts and join us on social media.

References

1. https://www.federalregister.gov/documents/2017/09/08/2017-19047/review-of-existing-general-regulatory-and-information-collection-requirements-of-the-food-and-drug

2. https://blogs.fda.gov/fdavoice/index.php/2017/09/fdas-plan-to-engage-the-public-in-the-agencys-new-effort-to-strengthen-and-modernize-fdas-regulatory-framework/