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March 27, 2020 - Coronavirus (COVID-19), FDA, Consumer Products, Emergency Use Authorization (EUA)
FDA Warns Against At-Home COVID-19 Testing Kits
By: Erin M. Bosman and Julie Y. Park
A number of startups announced they would begin selling at-home COVID-19 testing kits this week. These startups included: Carbon Health, a tech-enabled healthcare network that combines virtual and in-person care, Everlywell, a company that offers food sensitivity and various other home health tests, and
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March 26, 2020 - Coronavirus (COVID-19), TCPA
Text Messaging in a Time of COVID-19: FCC Guidance on “Emergency Messages” and Restrictions on Telemarketing in New York
By: Tiffany Cheung and Adam J. Hunt
With nearly half of the United States population being either urged or ordered to stay at home and avoid all non-essential travel in light of the COVID-19 crisis, modern forms of communication such as telephone calls, video chat, and, of course, text messaging, are
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March 24, 2020 - Coronavirus (COVID-19), FDA, Pharmaceutical & Medical Devices
FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked
By: Erin M. Bosman and Julie Y. Park
Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents communicating its policy on the manufacture of certain alcohol-based
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March 23, 2020 - Coronavirus (COVID-19), FDA, Product Liability, Pharmaceutical & Medical Devices
PREP Act Declaration Emboldens Drug and Device Industry to Innovate in the Face of a Growing Crisis
By: Erin M. Bosman and Julie Y. Park
COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public Readiness and Emergency Preparedness (PREP) Act encourages drug and medical
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March 17, 2020 - Coronavirus (COVID-19), FDA, Consumer Products
FDA and FTC Send Warning Letters to Companies Marketing Products to Treat Coronavirus; State Attorneys General Follow Suit
By: Erin M. Bosman and Julie Y. Park
The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) recently issued their first round of
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Topic Archives: Coronavirus (COVID-19)

FDA Warns Against At-Home COVID-19 Testing Kits

By: Erin M. Bosman and Julie Y. Park

Text Messaging in a Time of COVID-19: FCC Guidance on “Emergency Messages” and Restrictions on Telemarketing in New York

By: Tiffany Cheung and Adam J. Hunt

FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked

By: Erin M. Bosman and Julie Y. Park

PREP Act Declaration Emboldens Drug and Device Industry to Innovate in the Face of a Growing Crisis

By: Erin M. Bosman and Julie Y. Park

FDA and FTC Send Warning Letters to Companies Marketing Products to Treat Coronavirus; State Attorneys General Follow Suit

By: Erin M. Bosman and Julie Y. Park