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 2016: Navigating Legal Challenges in the Drug and Device Industries
Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries
CHB Chapters  CHB Chapters FDA Publishes Draft Guidance on Codevelopment of Companion Diagnostics (August 2, 2016) - Life Sciences 2016: Navigating Legal Challenges in the Drug and Device Industries, Wednesday, November 02, 2016
Amarin Pharma, Inc., Dr. Jonathan Herbst, Dr. Eric Rishe, Dr. Peter Gottesfeld, and Dr. Ralph Yung v. United States Food & Drug Administration, United States of America, Stephen Ostroff, M.D., and Sylvia Matthews Burwell, Case 1:15-cv-03588-PAE (S.D.N.Y. 2015) - Life Sciences 2016: Navigating Legal Challenges in the Drug and Device Industries, Wednesday, November 02, 2016
Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments, Department of Health and Human Services, Food and Drug Administration, 21 CFR Part 15 (September 1, 2016) - Life Sciences 2016: Navigating Legal Challenges in the Drug and Device Industries, Wednesday, November 02, 2016
Pacira Pharmaceuticals, Inc., Dr. Loren J. Harris, and Dr. Joseph W. Bell v. United States Food & Drug Administration; United States of America; Dr. Stephen Ostroff, United States Department of Health & Human Services, and Sylvia Mathews Burwell, Stipulation and Order, Case 1:15-cv-07055-LAK (S.D.N.Y. 2015) - Life Sciences 2016: Navigating Legal Challenges in the Drug and Device Industries, Wednesday, November 02, 2016
FDA Publishes Two Draft Guidances on Next Generation Sequencing Technology (July 18, 2016) - Life Sciences 2016: Navigating Legal Challenges in the Drug and Device Industries, Wednesday, November 02, 2016
Memo to The Honorable Sylvia Burwell from Committee on Energy and Commerce (May 26, 2016) - Life Sciences 2016: Navigating Legal Challenges in the Drug and Device Industries, Wednesday, November 02, 2016
Digital Health Innovation Action Plan - Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries, Thursday, October 05, 2017
FDA Initiates Software Precertification Pilot Program (August 3, 2017) - Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries, Thursday, October 05, 2017
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, Thursday, October 05, 2017
Web Segment  Web Segment FDA Regulation: Hot Topics - Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries, Thursday, October 12, 2017
Across the Pond – The European Medical Devices Directive and More - Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries, Thursday, October 12, 2017
MP3 Audio  MP3 Audio FDA Regulation: Hot Topics - FDA Regulation: Hot Topics, Thursday, October 12, 2017
Across the Pond – The European Medical Devices Directive and More - Across the Pond – The European Medical Devices Directive and More, Thursday, October 12, 2017
Transcripts  Transcripts FDA Regulation: Hot Topics - FDA Regulation: Hot Topics, Thursday, October 12, 2017
Across the Pond – The European Medical Devices Directive and More - Across the Pond – The European Medical Devices Directive and More, Thursday, October 12, 2017
MP4 - Mobile Video Seg  MP4 - Mobile Video Seg FDA Regulation: Hot Topics - FDA Regulation: Hot Topics, Thursday, October 12, 2017
Across the Pond – The European Medical Devices Directive and More - Across the Pond – The European Medical Devices Directive and More, Thursday, October 12, 2017
On-Demand Web Programs  On-Demand Web Programs Life Sciences 2017: Navigating Legal Challenges in the Drug and Device Industries, Wednesday, October 18, 2017, New York, NY
Live Seminar  Live Seminar Life Science 2018: Navigating Legal Challenges in the Drug and Device Industries, Friday, November 16, 2018, New York, NY
Live Webcast  Live Webcast Life Science 2018: Navigating Legal Challenges in the Drug and Device Industries, Friday, November 16, 2018, New York, NY
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