Regulatory Oversight, Food and Drug Administration (FDA), Infectious Diseases

Food and Beverage News and Trends - February 2025

DLA Piper on 2/10/2025

New Trump Administration tariffs on Canada, Mexico, and China. On February 1, 2025, President Donald Trump signed three Executive Orders instituting sweeping new tariffs on all goods imported from Canada, Mexico, and China,...more

FDA Provides Much-Needed Guidance on Master Protocols for COVID-19 Drugs

Morgan Lewis - As Prescribed on 6/1/2021

The US Food and Drug Administration (FDA) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent COVID-19. ...more

FDA cracks down on pharmaceutical firm for misbranding drug as COVID-19 treatment

Hogan Lovells on 10/26/2020

Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing the tally to five warning and untitled letters for the year. These...more

FDA Oversight of Laboratory-Developed Tests Continues To Evolve

Skadden, Arps, Slate, Meagher & Flom LLP on 10/3/2020

On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administration’s (FDA) oversight of laboratory-developed tests (LDTs)....more

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – September 2020 #1

Hogan Lovells on 9/3/2020

In Washington - White House Chief of Staff Mark Meadows on Tuesday said that there has been “real progress” in talks with congressional Democrats and Republicans on coronavirus relief legislation. ...more

HHS Limits FDA Oversight of LDTs Without Formal Rulemaking, Including During COVID-19 Pandemic

Morgan Lewis on 8/31/2020

The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it...more

FDA Expands Focus for COVID-19 Response

Mintz - Health Care Viewpoints on 5/6/2020

The Food and Drug Administration (FDA) continues to churn out policy statements, guidance documents, and emergency use authorizations (EUAs) to address the COVID-19 public health emergency. At the outset of the pandemic in...more

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