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Renal Denervation Researcher Argues Sham Control Is Ethically Necessary

This article was originally published in The Gray Sheet

Executive Summary

The lead investigator on the SYMPLICITY HTN-3 trial says sham-controlled trials are sometimes ethically necessary to prevent patients from undergoing ineffective treatments and warns there may be other medical devices on the market that are not as effective as previously thought.

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Q&A: Mark McClellan Discusses Gottlieb, Cures And More

Former FDA Commissioner Mark McClellan talked with Medtech Insight about FDA Commissioner-nominee Scott Gottlieb, who he has worked closely with in the past at FDA and CMS. He also discussed 21st Century Cures Implementation, President Trump's budget blueprint and more.

FDA Confirmation Watch: Gottlieb Likely To Face Questions About Approval Standards, Ties To Industry

Top HELP Committee Democrat Patty Murray tweeted concerns about Gottlieb's positions on the "gold standard" of FDA approval; Pubic Citizen's Michael Carome ultimately thinks Gottlieb will be approved.

Gottlieb At FDA: Industry Will Look For User-Fee Deal Support, Restrained Regulations

After months of waiting on whether President Trump would pick a conventional FDA commissioner candidate or go off the beaten path, the White House appears to be taking the former approach. Trump is expected to nominate Scott Gottlieb, a George W. Bush administration FDA alum, physician and long-time conservative voice on health policy. Gottlieb will favor reduced regulatory burdens, and industry hopes he will help push forward a device user-fee reauthorization agreement.

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