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Icon close orange D. Kyle Sampson

Insights 27 results

Client Alert

February 7, 2022
A Pandemic Silver Lining: FDA’s New Guidance on Using Digital Health Technologies for Clinical Investigations

Client Alert

December 30, 2021
FDA Issues Draft Guidances on Transitioning Devices from EUAs and Agency Enforcement Policies

Client Alert

August 27, 2021
FDA Rejects Bids To Market CBD-Based Dietary Supplements

Client Alert

August 6, 2021
FDA Finalizes “Intended Use” Regulations

Client Alert

May 5, 2021
Genus Medical Technologies LLC v. FDA: D.C. Circuit Holds FDA Cannot Regulate Devices as Drugs

Client Alert

April 22, 2021
Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid

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

February 2, 2021
USDA Issues Final Rule to Establish Domestic Hemp Production Program and Approve State and Tribal Oversight Plans

Client Alert

January 4, 2021
FDA Establishes – And HHS Immediately Withdraws – New OTC Drug User Fee Rates

Client Alert

November 30, 2020
Europe – Towards a More Harmonized Market for CBD?

Client Alert

October 26, 2020
France - Trial Period for Medical Use of Cannabis-Based Products

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