FDA & FTC Law

FDA granted emergency use authorization to Lucira Health Inc. for a COVID-19 self-testing kit. The EUA has numerous conditions that the manufacturer must meet.

FDA granted an Emergency Use Authorization to a COVID-19 vaccine developed by Pfizer, Inc. Doses of the vaccine have already been administered to health workers

Here’s why you need legal review of any information your healthcare company puts out on the Web: advertising claims can not only hurt, they can destroy your healthcare company.

The FDA examines whether medical devices comply with the regulations of the Food, Drug, and Cosmetic Act. Two of the most common violations medical device companies are charged are adulteration [...]

FDA and FTC warning letters continue to find violations of the FD&C Act when companies boast their products can cure or treat diseases such as COVID-19.

FDA might classify your cosmetics product as a new drug if you make disease claims for your cosmetics product. FDA also requires that you substantiate your claims and have safe ingredients

The FDA issues warning letters for numerous products including dietary supplements. FDA violations include findings that the supplement is a new drug, product adulteration, misbranding, and [...]

Jane’s Herbal Healthcare Startup is an ambitious collaboration with overseas physicians who use herbal medicine to treat certain diseases, based on some theory from another, indigenous system of [...]

A case study of the legal and regulatory concerns when a company wants to begin selling hemp and marijuana CBD products in California. The relevant federal and state laws are reviewed along with [...]

Avoid or mitigate potential FDA and FTC enforcement actions against stem cell and regenerative healthcare companies, including for false claims, by learning these legal keys