FDA Opens Door for Comments on Overhauling Many Regulations

Friday, September 8, 2017

The Food and Drug Administration is undertaking a wide-ranging review of its existing regulations and inviting the public to comment on policies that are duplicative, out of date or overly burdensome.

The FDA published seven federal register notices Thursday soliciting comments, opening the door for regulated industries and interest groups to weigh in on a wide array of rules for prescription drugs, medical devices, food safety and nutrition, tobacco products and veterinary drugs.

The move was related to one of President Donald Trump’s executive orders earlier this year instructing agencies to look at ways to reduce regulatory burdens.

“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,” Anna Abram, the FDA’s deputy commissioner for policy and planning, and a former health policy adviser to Sen. Richard Burr, R-N.C., said in a post on the FDA website.

FDA commissioner Scott Gottlieb also wants to update regulations in the interest of helping patients get access to innovative products. He spoke a Thursday forum hosted by the nonprofit group Research!America, a group that advocates for health and science research.

http://www.cq.com/doc/hbnews-5171856?6 (subscription required)

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Brenda Canine, PhD; McLaughlin Research Institute, Montana