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Medical Devices › Pharmaceutical Industry › Technology

McDermott Will & Emery

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

McDermott Will & Emery on

The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

Sheppard Mullin Richter & Hampton LLP

Day 1 Notes from the 42nd Annual J.P. Morgan Healthcare Conference

Sheppard Mullin Richter & Hampton LLP on

At the first day of the J.P. Morgan Healthcare Conference, “[T]he answer to the ultimate question of life, the universe and everything is 42.” Recognize that famous line? No, it’s not something from ChatGPT, it’s Douglas...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

Hogan Lovells

The European Commission releases an updated Borderline Manual for medical devices

Hogan Lovells on

The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is intended to assist manufacturers in...more

Stinson LLP

Off-Label Promotion —To Speak or Not To Speak?

Stinson LLP on

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more

Knobbe Martens

21st Century Cures Congressional Panel Unveils Medical Technology Proposals

Knobbe Martens on

On January 27, 2015, members of the House Commerce and Energy Committee unveiled a set of legislative proposals aimed at speeding up the development of new medical technology. The 21st Century Cures panel, a bipartisan...more

Searcy Denney Scarola Barnhart & Shipley

FDA Issues Draft Guidance on 510(k)

Searcy Denney Scarola Barnhart & Shipley on

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

Sheppard Mullin Richter & Hampton LLP

Thoughts on Regulatory Constraints of Business Models

Sheppard Mullin Richter & Hampton LLP on

I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more

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

Getting the Best Medical Care: a Newsletter from Patrick Malone - January 2013

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

In This Issue: - Six Things to Think About as Technology Advances - For More Information - Recent Health Care News You Should Know About - Check Out Our Previous Tips - Deep Thoughts for the New Year: Ethical...more

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