FDA
July 16, 2021 – In the News
James Boiani Quoted in “FDA Class I Medical Device Recalls on Track to Break Record in 2021”
BioWorld
August 28, 2020 – Article
False Claims Act Enforcement During the COVID-19 Pandemic and Beyond
Health Law Advisor Blog
George B. Breen, Alexis Boaz
August 26, 2020 – In the News
James Boiani Quoted in “Virus Testing Push Leaves FDA Lab Oversight in ‘a Bizarre Limbo’”
Bloomberg Health Law & Business News
August 25, 2020 – In the News
James Boiani Quoted in “Botched Covid Plasma Announcement Clouds FDA’s Vaccine Process”
Bloomberg Law Pharmaceutical & Life Sciences News
July 27, 2020 – Article
In Response to COVID-19, FDA Extends Enforcement Discretion for HCT/Ps Requiring Pre-Market Review
Health Law Advisor
Amy K. Dow
July 14, 2020 – Article
FDA to Resume Domestic Inspections with New Safety Measures After Temporary Pause Due to COVID-19 Health and Safety Concerns
Health Law Advisor Blog
Amy K. Dow, Sanchita Bose
June 29, 2020 – Article
Current Good Manufacturing Practices in the Time of COVID-19: FDA Announces New Expectations on Risk Assessment and Risk Management
Health Law Advisor Blog
James Boiani, Delia A. Deschaine
June 26, 2020 – Article
FDA PDMA Guidance in Response to COVID-19 Pandemic
Health Law Advisor Blog
Lauren Sullivan
June 23, 2020 – In the News
Bradley Merrill Thompson Quoted in “Device Makers Want FDA to Preview Post-Pandemic Flexibility Plans”
Inside Health Policy
April 29, 2020 – In the News
Bradley Merrill Thompson Quoted in “FDA Offers Psychiatric Device Flexibility, Expands ‘Wellness’ Definition”
Inside Health Policy
April 29, 2020 – In the News
Bradley Merrill Thompson Quoted in “How FDA Is Backing the Use of Artificial Intelligence in Telemedicine”
Wearable Technologies
April 24, 2020 – Article
FDA’s Support of AI in Telemedicine
MobiHealthNews
Bradley Merrill Thompson
April 21, 2020
FDA Authorizes the First Home Collection of Specimens to Be Tested for COVID-19
Health Law Advisor Blog
Megan Robertson, Priya Kaulich
April 22, 2020 – In the News
Bradley Merrill Thompson Quoted in “Akili’s Digital Therapeutic Launches Early for Housebound Children With ADHD”
MobiHealthNews
April 21, 2020 – In the News
Bradley Merrill Thompson Quoted in “FDA Eases Guidelines for New mHealth, Telemental Health Treatments”
mHealthIntelligence
April 16, 2020 – In the News
Bradley Merrill Thompson Quoted in “FDA: Devs Can Release Digital Products for Psychiatric Disorders Without 510(k) Submission During COVID-19 Crisis”
MobiHealthNews
April 10, 2020 – In the News
James Boiani Quoted in “Startups Spar with FDA Over What Constitutes a Home Coronavirus Test”
STAT News
March 31, 2020 – Article
FDA Issues Update to Guidance for Clinical Trials During the COVID-19 Pandemic
Health Law Advisor Blog
Amy K. Dow, Julie Lampley, Megan Robertson
March 30, 2020 – In the News
Bradley Merrill Thompson Quoted in “FDA Gives Guidance on ‘Coronavirus’ Thermal Fever Detection Systems”
IPVM
March 27, 2020 – In the News
Bradley Merrill Thompson Quoted in “Digital Health Advice from FDA Amid Coronavirus Leaves More Questions Than Answers”
Medtech Dive
March 24, 2020 – In the News
Bradley Merrill Thompson Quoted in “FDA Issues Emergency Guidance for Non-Invasive Remote Monitoring Devices”
Medical Device and Diagnostic Industry (MD+DI) Online
March 24, 2020 – Article
FDA Eases Device Modification Rules to Expand Availability of Ventilators During COVID-19 Pandemic
Health Law Advisor Blog
Ashley Creech, Bonnie Scott
March 24, 2020 – Article
FDA Confirms That At-Home Collection Kits Are Not Authorized for Use with COVID-19 Tests
Health Law Advisor Blog
Megan Robertson
March 23, 2020 – In the News
Bradley Merrill Thompson Quoted in “FDA Steps on Gas for Digital Health”
POLITICO Morning eHealth
March 20, 2020 – In the News
Bradley Merrill Thompson Quoted in “FDA Expands Use of Vital Sign Monitors to Enable Remote Care, Modifications During COVID-19 Emergency”
MobiHealthNews
March 20, 2020 – In the News
Bradley Merrill Thompson Quoted in “FDA Greenlights Expanded Remote Patient Monitoring to Keep Patients Out of Coronavirus-Slammed Hospitals”
Medtech Dive
March 19, 2020 – Article
FDA Issues Temporary Guidance on Food Supplier Verification Audit Requirements
Health Law Advisor Blog
Priya Kaulich
March 19, 2020 – Article
FDA Issues Guidance for Ongoing Clinical Trials During COVID-19 Pandemic
Health Law Advisor Blog
Amy K. Dow, Julie Lampley, Megan Robertson