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FDA Issues Two Guidances on Next Generation Sequencing
  • Reed Smith LLP
  • USA
  • April 24 2018

This guest post is from Reed Smith‘s Matt Jacobson, who is keeping us up to date with the FDA’s initiatives concerning pharmacogenomics and

FDA Guidance on Using Public Human Genetic Variant Databases for Genetic and Genomic-Based In Vitro Diagnostics
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • April 18 2018

On April 13, 2018, FDA issued final guidance on the Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and

New Data Requirements for Non-U.S. Clinical Investigations
  • Dykema Gossett PLLC
  • USA
  • April 12 2018

The U.S. Food and Drug Administration (FDA) recently issued a final rule describing the criteria for using clinical research data from clinical

FDA Approval for Auris’ Robotic Endoscopy Platform
  • Knobbe Martens
  • USA
  • April 11 2018

On March 23, Auris Health, Inc. announced FDA clearance for the Monarch Platform, Auris’ new system for robotic endoscopy. According to Auris Health

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar
  • Skadden Arps Slate Meagher & Flom LLP
  • USA
  • March 29 2018

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused

Connected medical device vulnerabilities continue to impact manufacturers, health care
  • Thompson Coburn LLP
  • USA
  • March 22 2018

Recently, Thompson Coburn’s Life Sciences Decoded blog described several FDA initiatives to increase the safety and reliability of the emerging

In Case You Missed It The Latest in AI News - March 19, 2018
  • Davis Wright Tremaine LLP
  • USA
  • March 19 2018

AI algorithms are only as good as their human creators, and early examples of missteps have already raised concerns over cultural and racial bias and

Clinical trials in China
  • Ropes & Gray LLP
  • China, Global
  • March 15 2018

A structured guide to clinical trials in China

Obtaining FDA clearance or approval of digital health products
  • Hogan Lovells
  • USA
  • March 14 2018

Many digital health products are regulated by the U.S. Food and Drug Administration (FDA) as medical devices or, when used in conjunction with a

FDA Draft Guidance on Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • March 9 2018

On February 16, 2018, FDA issued draft guidance describing the standardized format for electronic submission of data and information for all major (i