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Harmonizing the Common Rule and U.S. Food and Drug Administration Human Subjects Research Regulations

On September 28, 2022, the U.S. Food and Drug Administration issued two Notices of Proposed Rule Making to harmonize FDA’s regulations pertaining to human subjects research and the review of cooperative research by a single institutional review board with those of the Federal Policy for the Protection of Human Subjects. Earlier in September, FDA also issued a draft guidance entitled “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”

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State and Local Jurisdictions Impose Restrictions on Gatherings and Non-Essential Businesses: Defining What is, and is not, an “Essential Business” that Can Remain Open in Non-Remote Mode


Time to Read: 1 minutes Practices: Health Care

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Several jurisdictions recently imposed restrictions to limit the size of gatherings and close or reduce in-person operations of various “non-essential businesses,” all in order to slow the spread of COVID-19 through increased social distancing. Below, we summarize the restrictions and the exceptions for “essential businesses” applicable to dozens of jurisdictions. Because these public health recommendations (and in some cases, mandatory orders) are issued from the state and local/county/municipal levels of government, they are not uniform across the U.S., and their definitions of “essential businesses” may differ from state to state and from city to city. Close attention to the specific terms of these local and state department of health issuances is therefore critical. We offer this compendium in order both to give some current information about these local orders, as well as to demonstrate how these orders may differ geographically. 

View the PDF to read all recent orders.

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