Topic Archives: FDA

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 Nurx, an app that delivers prescriptions and STI testing kits. But ...›

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 hand sanitizers. Recognizing the significant supply disruptions for hand sanitizers, and ...›

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 device companies to increase production of existing products currently in short ...›

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 joint warning letters to several companies claiming their products—teas, essential oils, ...›

January 16, 2020FDA

2020 Under Dr. Stephen Hahn, FDA’s New Commissioner

Last month, Dr. Stephen Hahn was officially sworn in as the new commissioner of the U.S. Food and Drug Administration (FDA). The Senate confirmed him by a 73-17 vote. Hahn became the fourth leader of FDA in 2019 and the first confirmed nominee since former Commissioner Dr. Scott Gottlieb resigned unexpectedly in April and was ...›

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.” This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) Program. In conjunction with the end of the program, FDA also published ...›

Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer

The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption.  In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third Circuit’s holding that questions of pharmaceutical preemption should be decided by juries.  Merck Sharp & Dohme Corp. v. Albrecht et al., No. 17-290, slip op. (U.S. ...›

FDA Announces New Efforts to Combat Cybersecurity Threats in Medical Devices

FDA is tackling cybersecurity threats head-on and expects industry to do the same.  Earlier this month, FDA commissioner Scott Gottlieb, M.D., announced a series of developments designed to keep pace with evolving cybersecurity threats to medical devices.  Industry should take note, as these developments detail the agency’s current expectations for companies preparing to combat future ...›

Mixed Results on Class Certification for “Cereal” Plaintiff

In Hadley v. Kellogg Sales Company, Plaintiff Stephen Hadley, who has filed at least two additional lawsuits alleging the mislabeling of breakfast foods, sought certification of four California subclasses of purchasers of Kellogg’s cereal and cereal bar products.  On August 17, 2018, Judge Koh issued an order that carefully dissected Plaintiff’s request.  The court concluded ...›