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Department of Health and Human Services (HHS) Vaccinations Manufacturers

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

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

Alston & Bird

FDA Extends Pause on Non-mission-critical Domestic Surveillance inspections to February 4 – Medical Products Supply Chain Week in...

Alston & Bird on

In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more

White and Williams LLP

HHS Purports to Expand Civil Immunities Related to COVID-19 Vaccine

White and Williams LLP on

On December 3, 2020, in anticipation of one or more forthcoming COVID-19 vaccines, the U.S. Department of Health and Human Services (HHS) purported to broadly expand civil immunity from tort claims related to the manufacture,...more

Baker Donelson

OIG Approves Free Vaccine Refrigeration Systems in Physician Offices

Baker Donelson on

On September 16, 2016, the Department of Health and Human Services, Office of Inspector General (OIG) released Advisory Opinion 16-09, approving a refrigerator manufacturer’s proposal to install a vaccine storage and...more

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