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Medical Research › Medical Devices › Research and Development

Downs Rachlin Martin PLLC

Systematic review endorses integration of DTI imaging in clinical assessment of “mild” traumatic brain injury

Downs Rachlin Martin PLLC on

The use of diffusion tensor imaging (“DTI”) to assess mild Traumatic Brain Injury (mTBI) has been discussed in several prior posts. Also as discussed in prior posts, DTI evidence has been challenged in dozens of cases (the...more

J.S. Held

Inside the Healthcare Industry: The Impact of Human Factors & User Experience in Healthcare

J.S. Held on

Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more

McDermott Will & Schulte

Special Report: Developments in UK Life Sciences – Spring Update 2022

McDermott Will & Schulte on

MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Health Care Compliance Association (HCCA) on

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Research Compliance Conference - June 14th - 16th, 9:00 am - 5:00 pm CDT

Health Care Compliance Association (HCCA) on

Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more

McDermott Will & Schulte

[Webinar] Around the Corner: Evolving Opportunities and Challenges for Real-World Evidence and Data-Powered Solutions - August...

McDermott Will & Schulte on

Healthcare research has faced severe disruption during the COVID-19 public health emergency and underscored the need for novel technological solutions that harness and utilize data beyond traditional clinical research models....more

Smart & Biggar

COVID-19 developments – federal government issues request for information for alternative suppliers for certain pharmaceuticals

Smart & Biggar on

The federal government has been proactive in seeking help from industry in tackling the pandemic. For example, Health Canada contacted Health Product Licence Holders to let them know specific areas where they may be able to...more

Hogan Lovells

The importance of conscientious health data collection in European clinical trials

Hogan Lovells on

Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more

Wilson Sonsini Goodrich & Rosati

FDA Outlines Considerations for the Development and Labeling of Companion Diagnostics for Use with a Specific Group or Class of...

Wilson Sonsini Goodrich & Rosati on

Recently, the U.S. Food and Drug Administration, or FDA, issued a draft guidance (the guidance) outlining considerations for the development and labeling of in vitro companion diagnostics to support indicated uses for...more

Ballard Spahr LLP

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

Ballard Spahr LLP on

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

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