News & Analysis as of

Food and Drug Administration (FDA) Generic Drugs Coronavirus/COVID-19

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

King & Spalding

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

King & Spalding on

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

Alston & Bird

Alston & Bird Health Care Week in Review - October 2021 #5

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

McGuireWoods Consulting

Washington Healthcare Update - September 2021

This week in Washington: Reconciliation markups begin. Congress  - Upcoming Hearings/Markups - House - • Need for Continuing Resolution to Fund the Government...more

Mintz - Health Care Viewpoints

Recent Amendments to the FDA Laws Attempt to Clarify and Improve Existing Systems

Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - May 2020

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – May 2020 #12

Hogan Lovells on

In Washington: Sen. Debbie Stabenow (D-MI) and Senate Minority Leader Chuck Schumer (D-NY) will be launching a messaging campaign on “the cost of Republican inaction during the COVID-19 crisis.”  Schumer said President...more

McDermott Will & Schulte

CARES Act Reforms to Address Drug and Device Shortages and Updates to the OTC Drug Monographs

On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, into law in response to the COVID-19 pandemic. Among other healthcare-related provisions, the CARES Act addresses...more

Holland & Hart - Employers' Lawyers

HEALTHCARE: Health Provisions/Medicare & Medicare Extenders/OTC Drugs

The CARES Act adopts several measures to help stabilize the healthcare system, address health care issues directly and indirectly related to the current pandemic and ensure future preparedness. It also allocates $100 billion...more

Mintz - Health Care Viewpoints

Coronavirus Relief Bill Includes Surprise Addition: OTC Monograph Reform Bill Becomes Law

As a follow up to our recent blog post, FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round, President Trump signed the bipartisan over-the-counter (OTC) monograph reform bill into law on March 27, 2020....more

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