News & Analysis as of

New Guidance Coronavirus/COVID-19 Regulatory Reform

Morgan Lewis - As Prescribed

Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more

Seyfarth Shaw LLP

DOJ Withdraws Eleven ADA Guidance Documents For Public Accommodations

Seyfarth Shaw LLP on

The Trump DOJ rescinded five COVID-19 related documents and six older guidance documents designed to educate businesses on the requirements of the ADA, claiming that the recission will reduce the burden on businesses to...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

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