FacultyFaculty/Author Profile
Scott D. Danzis

Scott D. Danzis

Covington & Burling LLP

Washington, DC, USA


Scott Danzis is a partner in the firm’s Food & Drug and Health Care practice groups. His practice focuses primarily on the regulation of medical devices, but also includes regulation of drugs, biologics, and tobacco products. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements, postmarket reporting, recalls, and enforcement actions.

From 2006 to 2008, Mr. Danzis served as the Special Assistant to the Chief Counsel of the U.S. Food and Drug Administration. While at FDA, he was broadly involved in a wide range of legal and regulatory matters related to medical devices and drugs. He also worked on implementing key provisions of the Food and Drug Administration Amendments Act of 2007.

Scott D. Danzis is associated with the following items:
Course Handbooks  Course Handbooks Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries
Life Sciences 2018: Navigating Legal Challenges in the Drug and Device Industries
CHB Chapters  CHB Chapters FDA Releases Details and Timelines in Its Digital Health Innovation Action Plan (August 3, 2017) - Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries, Friday, October 06, 2017
FDA Initiates Software Precertification Pilot Program (August 3, 2017) - Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries, Friday, October 06, 2017
Digital Health Innovation Action Plan - Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries, Friday, October 06, 2017
FDA Outlines Updated Approach to Regulating Digital Health Technologies (December 20, 2017) - Life Sciences 2018: Navigating Legal Challenges in the Drug and Device Industries, Friday, November 16, 2018
Digital Health Checkup: Key Questions Market Players Should Be Asking (Part One) (August 29, 2017) - Life Sciences 2018: Navigating Legal Challenges in the Drug and Device Industries, Friday, November 16, 2018
ICO Consults on Privacy “Regulatory Sandbox” (September 17, 2018) - Life Sciences 2018: Navigating Legal Challenges in the Drug and Device Industries, Friday, November 16, 2018
Digital Health Checkup (Part Two): Key Commercial Questions When Contracting for Digital Health Solutions (September 26, 2017) - Life Sciences 2018: Navigating Legal Challenges in the Drug and Device Industries, Friday, November 16, 2018
Digital Health Checkup (Part Three): Key Questions About AI, Data Privacy, and Cybersecurity (December 5, 2017) - Life Sciences 2018: Navigating Legal Challenges in the Drug and Device Industries, Friday, November 16, 2018
Live Seminar  Live Seminar Life Sciences 2019: Navigating Legal Challenges in Drug and Device Industries, Thursday, October 10, 2019, New York, NY
Live Webcast  Live Webcast Life Sciences 2019: Navigating Legal Challenges in Drug and Device Industries, Thursday, October 10, 2019, New York, NY
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