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Troutman Pepper

New FDA Guidance on AI and Medical Products

Troutman Pepper on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Robinson+Cole Health Law Diagnosis

HHS Again Requires FDA Premarket Review for COVID-19 Tests

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more

Bricker Graydon LLP

ODH issues guidance on redistributing COVID-19 vaccine doses

Bricker Graydon LLP on

On January 15, 2021, the Ohio Department of Health (ODH) released COVID-19 Vaccine Redistribution Guidance for enrolled COVID-19 vaccine providers....more

Faegre Drinker Biddle & Reath LLP

FDA Gives Guidance on Reporting Medical Device Shortages

Last week, FDA released guidance for life sciences manufacturers that produce medical devices and components “critical to public health,” including materials that support or sustain life, or are used in emergency care or...more

Fisher Phillips

California Issues COVID-19 Guidance To Life Sciences Employers

Fisher Phillips on

Thanks to new directives from state health officials, life sciences employers in California will need to immediately create and implement a worksite specific plan to address transmission of COVID-19 in the workplace. The...more

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

Morgan Lewis on

The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

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