Showing all posts written by Mark Davis
Mr. Davis earned his Bachelor of Science in Mechanical Engineering at Brigham Young University, where he competed in the international University Rover Challenge. After graduation, he worked as a regulatory compliance engineer at Novarad, a small medical device company.
Following his work as an engineer, Mr. Davis attended the University of Texas School of Law. At Texas, he was an officer in the Texas IP Law Society and served as an associate editor of the Texas Law Review. He also represented small business owners and nonprofit groups as a member of the Texas Clinical Law Programs.
He joined the firm in 2015. Click here to read full bio
Best Practices, LLC recently released a study that provides insights into the amount of resources pharmaceutical and medical device companies allocate to ensure their products meet quality and regulatory standards. The study includes
The FDA recently announced its approval of GW Pharmaceutical’s Epidiolex drug, described as the first ever plant-derived cannabinoid medicine in the United States. The announcement notes that Epidiolex contains a highly purified
Cyberdyne, Inc. recently announced FDA marketing approval for its Medical HAL [Hybrid Assistive Limb] therapeutic device and services. Cyberdyne describes itself as a Japanese company founded by Professor Yoshiyuki Sankai of the University
The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications and interactions with FDA.” The FDA provides this draft guidance following
Kalytera Therapeutics, clinical-stage pharmaceutical company, recently announced plans for clinical trials focused on the treatment of Graft versus Host Disease using Cannabidiol (CBD), a compound found in cannabis. This development
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 combined
Forward Pharma A/S (“Forward”) recently announced that a necessary super majority of its shareholders have approved a settlement of various patent disputes with two wholly-owned subsidiaries of Biogen Inc. (“Biogen”)
The third annual Security of Things® Forum (SECOT) in Cambridge, Massachusetts fostered discussion on a variety of cyber-security related topics ranging from a standards-based approach to security connected devices to connected healthcare
IBM’s Watson for Genomics and the U.S. Department of Veterans Affairs (VA) just announced a public-private research partnership to study genomics and provide tailored medical solutions to patients. This partnership is poised to
On January 26, 2016, the FDA offered for public comment its draft guidance on medical devices and interoperability, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices—Draft Guidance
“There is no such thing as a threat-proof medical device.”
Suzanne Schwartz, M.D., MBA, director of emergency preparedness and medical countermeasures at the FDA’s Center for Devices and Radiological Health.
Two months after finalizing