FDA Uses EUAs Broadly in the Fight Against COVID-19

On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel …›

HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation

On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to clarify the scope of immunity that accompanies developing and deploying countermeasures to COVID-19. The PREP Act grants tort liability …›

CPSC Recall Remedies in the Time of COVID-19

The Consumer Product Safety Commission (CPSC) recognizes that companies everywhere are in the midst of responding to the impact of COVID-19 on business operations, including government stay-at-home orders that could see some operations temporarily close. Given these “extraordinary circumstances,” the CPSC issued a notice …›

FDA Inspires Modifications and Quick Authorizations for Ventilators

As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical facilities equipped with life-saving ventilators. Ventilator Modification Enforcement Policy On …›

FDA Warns Against At-Home COVID-19 Testing Kits

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 …›

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

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 …›

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

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 …›

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

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 …›