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Elaine H. Tseng
Insights 36 results
Client Alert
March 10, 2022
France - A Charter for the Promotion of Medical Devices (Including IVD)
Client Alert
March 1, 2022
The Wait is Over: FDA Releases Proposed Rule to Align the U.S. Medical Device Quality Regulation with International Standards
Client Alert
February 7, 2022
A Pandemic Silver Lining: FDA’s New Guidance on Using Digital Health Technologies for Clinical Investigations
Client Alert
November 9, 2021
A Magic Mixing Cauldron for the 21st Century: FDA’s new guidances on using real-world data in regulatory decision-making
Client Alert
Client Alert
June 3, 2021
The End of Enforcement Discretion for Cell & Gene Therapies: Thinking Through Next Steps
Client Alert
April 20, 2021
FDA Reverses HHS Exemption of Class I and Class II Medical Devices from Section 510(k)
Article
March 11, 2021
Biden Administration - What's Ahead for the Life Sciences Industry?
Client Alert
February 5, 2021
FDA Appoints Renowned Cybersecurity Researcher to Head Agency's Medical Device Cybersecurity Efforts
Client Alert
August 17, 2020
Federal Government Takes Steps Toward Enforcement of ClinicalTrials.gov Requirements
Client Alert
March 23, 2020
U.S. and EU Regulators and Institutions Issue Guidance on Clinical Trial Conduct during COVID-19 Pandemic
Article · Source: Law360
March 19, 2020
Ruling In HHS Case May Mean More Drug Trial Reporting