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Medical Devices › Pending Legislation

Akin Gump Strauss Hauer & Feld LLP

Senate Passes Long-Awaited FDA User Fee Package

Akin Gump Strauss Hauer & Feld LLP on

Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more

Patrick Malone & Associates P.C. | DC Injury...

Don’t give medical device makers more time before disclosing product woes

Patrick Malone & Associates P.C. | DC Injury... on

Pro-business and anti-consumer lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed...more

Knobbe Martens

Bills Introduced to Streamline FDA Review of Medical Devices

Knobbe Martens on

U.S. Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) recently introduced the Rare Device Innovation Act and the FDA Regulatory Efficiency Act.  The bills, if passed, would streamline the U.S. Food and Drug Administration...more

Buchalter

State Law Obstacles to the National Distribution of eHealth Medical Devices Directly to Consumers

Buchalter on

The latest and greatest eHealth medical devices directed to consumers are technologically advanced and consumer-friendly. They have the capacity to diagnose certain health conditions and generate treatment plans and...more

Foley & Lardner LLP

Telehealth Commercial Coverage and Parity Laws: Trends, Challenges and Opportunities

Foley & Lardner LLP on

There will always be differences among state laws on telehealth coverage, but what is remarkable is the rapidly increasing pace at which states have been adopting coverage statutes in the last few years, with currently 29...more

Arnall Golden Gregory LLP

Arnall Golden Gregory Series Explains Provisions in the 21st Century Cures Act

Arnall Golden Gregory LLP on

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new...more

BakerHostetler

Pharmacy Benefit Manager Group Opposes 21st Century Cures Act’s Cost Offset

BakerHostetler on

The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care...more

BakerHostetler

21st Century Cures Act Passes House Committee

BakerHostetler on

The House Energy and Commerce Committee unanimously approved H.R. 6, the “21st Century Cures Act,” on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill). Often described as a “landmark...more

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