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Medical Devices › Proposed Regulation › Life Sciences

Blake, Cassels & Graydon LLP

Health Canada Proposes Regulations to Mitigate Drug and Medical Device Shortages

Blake, Cassels & Graydon LLP on

Health Canada recently published draft regulations to address therapeutic product shortages in Canada. The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of...more

Smart & Biggar

Health Canada’s proposed regulatory amendments to address health product shortages

Smart & Biggar on

On June 25, 2024, Health Canada published a notice of intent and Building resilience: Health Canada’s plan to address health product shortages, 2024 to 2028, relating to Health Canada’s plan over the next 4 years to address...more

Paul Hastings LLP

From General Discretion to Agency Authority? FDA’s Bold Bid to Regulate Laboratory Developed Tests

Paul Hastings LLP on

After years of FDA discussion and failed congressional efforts to assert greater oversight of laboratory developed tests (LDTs), FDA has proposed a rule that would require many LDTs to comply with FDA’s requirements for in...more

McDermott Will & Schulte

Laboratory-Developed Tests: FDA Publishes Highly Anticipated Proposed Rule

McDermott Will & Schulte on

On September 29, 2023, the US Food and Drug Administration (FDA) published a long-awaited proposed rule on laboratory-developed tests (LDTs). If FDA finalizes this rule as proposed, FDA will regulate virtually all LDTs as...more

Latham & Watkins LLP

UK’s MHRA Publishes Response to Consultation on Future Medical Devices Regulation

Latham & Watkins LLP on

The response includes a considered implementation plan to strengthen the regulation of medical devices and in vitro diagnostics, improve patient safety, and foster innovation post-Brexit. On 26 June 2022, the UK Medicines...more

Foley Hoag LLP

Harmonization Is Key: FDA’s Proposed Rule Seeks to Revamp Medical Device Quality System Regulation

Foley Hoag LLP on

On February 23, 2022, the U.S. Food and Drug Administration (FDA) issued a proposed rule seeking to amend the medical device current good manufacturing practice requirements of the Quality System Regulation (QSR). Currently,...more

Epstein Becker & Green

[Webinar] Shaping the Future of Artificial Intelligence (AI) Within Life Sciences - September 30th, 9:00 am - 10:15 am ET

Epstein Becker & Green on

Amy Dow and Brad Thompson, Members of the Firm, speak on “Shaping the Future of Artificial Intelligence (AI) Within Life Sciences,” a virtual program co-hosted by Simmons & Simmons and Epstein Becker Green. On both sides of...more

Mintz - ML Strategies

What You Need to Know: State and Federal Updates Related to COVID-19

Mintz - ML Strategies on

...On Monday, House Speaker Nancy Pelosi, Majority Whip James Clyburn, Transportation & Infrastructure Committee Chairman Peter DeFazio, and Energy & Commerce Committee Chairman Frank Pallone held a press conference on a...more

Hogan Lovells

FDA wants to hear from you: Proposed framework for regulating output of digital health tools accompanying prescription drugs as...

Hogan Lovells on

On 20 November the Food and Drug Administration (FDA) published a request for comments on a proposed framework for regulating the output of digital health applications disseminated by or on behalf of drug manufacturers with...more

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