News & Analysis as of

Medical Devices Consolidated Appropriations Act (CAA)

Dechert LLP

Dechert Re:Torts - Key Developments in Product Liability and Mass Torts - Issue 10

Dechert LLP on

Senators Focus Attention on Litigation Funding’s Opacity - Building on the momentum we previously noted related to litigation funding, on September 14, Senator John Kennedy introduced the Protecting Our Courts from Foreign...more

Ankura

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

Ankura on

On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

Sheppard Mullin Richter & Hampton LLP

FDA To Require Demonstration of Cybersecurity Safeguards for Pre-Market Submissions of Certain Medical Devices

On March 29, 2023, and March 30, 2023, the U.S. Food & Drug Administration (“FDA”) issued a series of FAQs and a guidance document clarifying the agency’s intended implementation of the Consolidated Appropriations Act of 2023...more

Mintz - Health Care Viewpoints

FDA’s Digital Health High Notes from 2022

There has been a lot of discussion lately of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which was enacted on December 29, 2022 as part of the larger Consolidated Appropriations Act for 2023 (you can find our blog...more

MoFo Life Sciences

FDORA Passage Brings Significant Changes To FDA’S Drug, Device, And Cosmetic Authorities

MoFo Life Sciences on

The Consolidated Appropriations Act for 2023 was signed into law on December 29, 2022 and includes the Food and Drug Omnibus Reform Act (FDORA). FDORA authorizes a variety of new and important amendments to the Food, Drug,...more

Akin Gump Strauss Hauer & Feld LLP

Congress’ Year-End Appropriations Package Brings FDA Legislative Changes, Leaves Unresolved Policy Issues

In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes. Although the Senate Health, Education, Labor and Pensions...more

Mintz - Health Care Viewpoints

FDA’s Holiday Present from Congress: Bipartisan Reforms to the Accelerated Approval Framework, Long-Awaited Cosmetic...

On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act for 2023, colloquially referred to as the omnibus funding bill, that includes a similarly expansive and diverse piece of legislation...more

Skadden, Arps, Slate, Meagher & Flom LLP

Trend Toward Broader Communication Continues as Congress Codifies Life Sciences Companies’ Ability To Share Product Information...

Embedded in the thousands of pages of the Consolidated Appropriations Act of 2023 (the omnibus legislation) that President Joe Biden signed into law on December 29, 2022, is a section that amends the Food, Drug and Cosmetic...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more

Cooley LLP

Blog: Key Health-Related Provisions Tucked into Year End Spending Bill

Cooley LLP on

Last week, Congress passed and the President signed into law the Consolidated Appropriations Act of 2016 (“the Omnibus”). This legislation contains both $1.1 trillion in government spending for FY16 as well as $650 billion...more

10 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide