News & Analysis as of

Medical Devices › Good Clinical Practices

McGuireWoods LLP

Medical Device Legal News with Sam Bernstein: Episode 9

McGuireWoods LLP on

The US Supreme Court rules that, under the Federal False Claims Act (FCA), the knowledge and subjective beliefs of a defendant at the time a false claim was submitted are determinative, and post hoc objectively reasonable...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

Faegre Drinker Biddle & Reath LLP

FDA Issues Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic

Faegre Drinker Biddle & Reath LLP on

As the COVID-19 pandemic continues to alter ways of life across the globe, clinical trials must be adapted for participant safety while maintaining accuracy in the midst of the ongoing crisis. In September 2020, the U.S. Food...more

Seyfarth Shaw LLP

FDA Authorizes Synthetic Nasal Swab to Increase COVID-19 Testing

Seyfarth Shaw LLP on

Late last week, the U.S. Food and Drug Administration (FDA) announced it approved the use of spun synthetic swabs similar to Q-tips for use in testing for COVID-19....more

Hogan Lovells

The global impact of COVID-19 on clinical trials and countermeasure development

Hogan Lovells on

The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more

Skadden, Arps, Slate, Meagher & Flom LLP

The 10 Most Important Changes in the New and Improved AdvaMed Code of Ethics

Skadden, Arps, Slate, Meagher & Flom LLP on

At the close of 2018, the Advanced Medical Technology Association (AdvaMed) released an updated version of its Code of Ethics governing medical technology manufacturers in their interactions with health care professionals...more

Morgan Lewis

FDA Issues Final Rule on Data Acceptance from Clinical Investigations for Medical Devices

Morgan Lewis on

The US Food and Drug Administration’s new requirements for sponsors to follow Good Clinical Practices (GCPs) for ex-US device clinical trials will affect device development strategies, including where to conduct such trials....more

Robinson+Cole Health Law Diagnosis

FDA Amends Regulations For Data From Foreign And Domestic Investigation For Medical Devices

Robinson+Cole Health Law Diagnosis on

On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as...more

Knobbe Martens

INC Research Merges with inVentiv Health Creating a $7.4B Combined Entity

Knobbe Martens on

According to press releases, INC Research Holdings, Inc. has agreed to merge with inVentiv Health, creating a combined company having an enterprise value of approximately $7.4 billion. The press release further notes that the...more

King & Spalding

FDA Releases Revised Draft Guidance on the Distribution of Scientific and Medical Publications About Unapproved Uses: Guidance...

King & Spalding on

On March 3, 2014, the U.S. Food and Drug Administration (FDA) released a revised draft guidance entitled, “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (“Revised Draft...more

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