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HHS Clinical Trial Guidance Sparks More Questions From Researchers

This article was originally published in The Gray Sheet

Executive Summary

Draft guidance from the Department of Health and Human Services' Office of Human Research Protections leaves lingering questions about how to proceed when subjects withdraw from a clinical trial, stakeholders say

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Can OTC tests be 510(k) exempt?: A Dec. 1 citizen petition seeks FDA clarification on whether Class I in vitro diagnostics sold over the counter are eligible for 510(k) exemption. On behalf of an unnamed client, Hyman, Phelps & McNamara attorney Jeffrey K. Shapiro asks the agency for a formal advisory on a regulation that excludes "near patient testing (point of care)" Class I tests from pre-market notification exemptions. "We believe that this 'near patient' or 'point of care' category applies to testing performed outside a laboratory environment by a health care professional [and] does not include over-the-counter tests intended for lay users," he writes. FDA actions have been "inconsistent" on the issue, according to Shapiro

Piramal Profits As It Sheds DRG To Clarivate For $950m

An experienced hand at M&A, Ajay Piramal has done it again – this time selling Decision Resources Group to Clarivate Analytics for $950m. Apart from $900m in cash, Piramal Enterprises will get a stake in Clarivate while the latter expects the acquisition to be earnings-accretive in 2020.

QUOTED. 20 January 2020. Henrik Berggren.

San Francisco-based digital health start-up Steady Health has launched the first "virtual" full-service diabetes clinic for patients in California. See what Henrik Berggren, CEO and founder of Steady Health, said about it here.

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