We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results:1-10 of 253

Regulatory Challenges for the New Frontier of Medical Imaging: Terahertz Spectrum
  • Mintz
  • USA
  • November 15 2018

Emerging medical imaging technologies being developed for the terahertz spectrum may face regulatory hurdles from an unexpected Federal agency: the


ML Strategies Health Care Lame Duck Preview
  • Mintz
  • USA
  • November 2 2018

With the opioid bill passed, the House on recess and the Senate having cut a deal to get out the door, we all begin to wonder: after the dust settles


Fall 2018 Agency Rule List & FDA Device Center Guidance Priorities
  • Mintz
  • USA
  • October 24 2018

On October 17th, the Administration released its semiannual forecast of the rules that the Department of Health and Human Services (HHS) will be


FDA Responds to Device Software Vulnerabilities by Releasing New Draft Cybersecurity Guidance
  • Mintz
  • USA
  • October 22 2018

On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which


Strategies to Unlock AI's Potential in Health Care, Part 2: FDA’s Approach to Protecting Patients & Promoting Innovation
  • Mintz
  • USA
  • October 18 2018

Artificial intelligenceAIis the future of everything. But when patient health is on the line, can we trust algorithms to make decisions instead of


FDA's Drug Centers Release New Draft Guidance on Quantitative Info in Consumer-Directed Ads
  • Mintz
  • USA
  • October 17 2018

In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer (DTC) promotion of prescription drugs and


Trump Administration Proposes Requiring Disclosure of Drug Prices in TV Ads
  • Mintz
  • USA
  • October 17 2018

The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week


Medical Devices and the Intersection between FDA and Patent Law
  • Mintz
  • USA
  • October 5 2018

Regulatory compliance is often treated as completely independent from development or enforcement of patent rights. This situation is not helped by the


Delaware Court Finds “Material Adverse Effect” Allows Buyer to Terminate Merger Agreement
  • Mintz
  • USA
  • October 3 2018

In a 246-page opinion issued on October 1, 2018, the Delaware Court of Chancery ruled that German pharmaceutical company Fresenius Kabi AG validly


ML Strategies Weekly Health Care Preview - Week of October 1, 2018
  • Mintz
  • USA
  • October 1 2018

You might have missed it but Congress averted a government shutdown last week. While several appropriations bills passed on time for the first time in