News & Analysis as of

Vaccinations Regulatory Requirements Food and Drug Administration (FDA)

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

Goodwin

UK’s MHRA Grants Marketing Authorization for Chikungunya Vaccine

Goodwin on

On February 5, 2025 Valneva SE (“Valneva”) announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Valneva’s chikungunya vaccine, IXCHIQ. ...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

Foley Hoag LLP

FDA Releases First New COVID-19 Vaccine BLA Guidance Since 2020

Foley Hoag LLP on

Executive Summary - On October 19, 2023, the Food and Drug Administration (FDA) released a final guidance document titled Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry, providing...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

Bricker Graydon LLP

What health care providers need to know as COVID-19 vaccines arrive in Ohio

Bricker Graydon LLP on

With news that the Pfizer-BioNTech COVID-19 vaccine has been granted emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), health care providers should be preparing for the months of distribution...more

Haug Partners LLP

Understanding the FDA’s Medical Products Clinical Trial Guidance amidst COVID-19

Haug Partners LLP on

Conducting medical product clinical trials during the COVID-19 public health emergency presents unprecedented challenges. In light of the challenges presented by COVID-19, the Food and Drug Administration (FDA) issued...more

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