News & Analysis as of

Vaccinations Regulatory Requirements Department of Health and Human Services (HHS)

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

Cozen O'Connor on

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Alston & Bird

Health Care Week in Review | Senate Passes First Budget Resolution; DOJ Opts to Continue Defense in Braidwood SCOTUS Case

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Cozen O'Connor

COVID Vaccine No Longer Required for Adjustment of Status Applicants

Cozen O'Connor on

On January 22, 2025, USCIS posted an alert pertaining to the I-693 immigration medical exam required for most individuals applying to become lawful permanent residents. USCIS indicates that they now “waive[s] any and all...more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Vaccination Program

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-11 (the “Opinion”), to a pharmaceutical manufacturer (the...more

Sheppard Mullin Richter & Hampton LLP

Tracking the Waivers: Implications of the Wind Down of the COVID-19 Public Health Emergency

The White House recently announced that the COVID-19 national emergency and public health emergency (PHE) declarations will end on May 11, 2023. These declarations have been in place since the beginning of the COVID-19...more

Alston & Bird

Alston & Bird Health Care Week in Review - January 2022 #4

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

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