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Fifth Amendment to PREP Act Declaration expands "covered persons" to increase workforce authorized to administer COVID-19 vaccines

On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) issued its fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) related to COVID-19...more

Election 2020 Snapshot: Helping our clients make sense of the U.S. election results

On Tuesday, November 3, 2020, Americans chose the presidency and the makeup of the United States Congress. With the U.S. election now decided, with the exception of the Georgia Senate races, we are delighted to share with you...more

Election 2020 Snapshot: Impacts of the U.S. election for the life sciences and health care industry

On November 19, leaders of our Life Sciences and Health Care team met for a panel discussion of the impacts on the industry of the 2020 U.S. election. This was the first event in a series of conversations, with other webinars...more

Comment period ending for proposal to automatically sunset HHS/FDA/CMS regulations

The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations issued by HHS or its constituent...more

Election 2020 Snapshot: Helping our life sciences and health care clients make sense of the U.S. election results

President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug pricing reform efforts. These actions...more

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Tuesday, 13 October 2020 - The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. President Trump and his aides on Friday...more

Will FDA be forced to implement a drug importation program?

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

FDA Chief of Staff: OTC reform remains “top priority” for FDA

Speaking Tuesday, May 21, at the Consumer Health Products Association Regulatory, Scientific, and Quality Conference, FDA Chief of Staff Lauren Silvis emphasized that over-the-counter (OTC) monograph reform remains a “top...more

FDA proposes new ways for prescription drugs to become available over-the-counter

On Tuesday, FDA’s Center for Drug Evaluation and Research (CDER) announced a draft guidance titled “Innovative Approaches for Nonprescription Drug Products” that could aid drug manufacturers who want to sell, without a...more

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