FDA & FTC Law

FDA Warning Letters are formal notifications issued when the FDA finds significant regulatory violations in areas like labeling, marketing, or manufacturing practices. While a warning letter [...]

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) finely regulate the promotion compliance of medical devices—both in terms of the claims made and in the manner of [...]

The Federal Trade Commission is beginning to require that marketing companies understand that the collection, use, and sale of consumer location information requires the consent of the consumer

In the last decade, the FDA’s Center for Devices and Radiological Health (CDRH) has implemented many new programs to help developers obtain authorization of medical devices

The FDA recently approved the drug, of Leqembi, a treatment of Alzheimer’s disease, through the accelerated approval process.

Many metaverse augmented reality, virtual reality, artificial intelligence, and other med-tech applications will need to meet FDA medical device requirements.

Integrative cardiology practitioners, doctors and non-physicians, need to review their working relationship for violations of state licensing laws, HIPAA, self-referral laws, and other legal [...]

The HHS Office of Civil Rights has guidance on how and when covered entities should respond to a right of access request for the personal health information of a patient.

The Food and Drug Administration issues a press release that said, even though the pandemic is severe, patients should receive the mRNA vaccines in two properly timed doses.

Johnson & Johnson’s adenovirus-based vaccine for preventing the transmission of COVID-19 is expected to be reviewed by the Food and Drug Administration in February 2021.

FDA is sending warning letters to companies that claim the company can diagnose COVID-19. FDA has granted an Emergency Use Authorization) for at least one at-home testing kit.

An Advisory Panel for the Food and Drug Administration is reviewing a request by Moderna for its COVID-19 vaccine. Moderna’s vaccine is expected to be distributed in the coming months.

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

Regenerative medicine includes many treatments and products such as stem cell therapy, PRP, and gene therapy. An experienced stem cell and regenerative medicine lawyer can explain the FDA requirements.

The Farm Bill of 2018 legalized CBD products that are hemp based for certain pharmaceutical uses. Food and dietary supplement possibilities may follow. Many different federal and state laws and [...]

Regenerative medicine includes products and treatments that can be regulated by the Food and Drug Administration. The laws are changing as this industry evolves.

The legalization of many CBD oil products has opened the door to many new business opportunities. It is critical to review how each product is manufactured, classified, branded, marketed, and [...]

Makers of health care products and health care providers need to understand the FTC guidelines on soliciting endorsements, affiliate marketing, employee endorsements, and permissible testimonials [...]

Answers to commonly asked questions about the new Federal Trade Commission (FTC) endorsement guidelines.

Common FDA mistakes that cause healthcare companies to get sued

Healthcare venture should always look out for unlicensed practice of medicine issues.

Starting a healthcare company without having prior FDA legal and regulatory review can place your company in serious jeopardy.

The FDA has developed new guidelines that expand the safety requirements and manufacturing standards for stem cell treatments.

Learn how to avoid these FDA legal traps when marketing your dietary supplement product.

Wondering how to get your OTC drug to market? This FDA OTC drug primer tells you how.

Your dietary supplement products could be regulated as a new drug by FDA, unless you pay attention to these regulatory fundamentals.

As they say in Game of Thrones, “Winter is Coming.” It’s a grim statement that reminds everyone that ahead is nothing but snow and ice. When you’re preparing to launch your dietary supplement [...]