FDA Warning Letters – COVID-19 Testing Kits

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.

FDA Reviewing Moderna’s COVID-19 Vaccine

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 Approves Authorized Use of a COVID-19 Test Product

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 Issues Emergency Use Authorization for Pfizer COVID-19 Vaccine

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


June Roundup of FDA and FTC Warning Letters To Healthcare Companies Claiming COVID 19 Treatments and Cures

The Federal Trade Commission (FTC) and Federal Drug Administration (FDA) are continuing to send warning letters to companies that promise treatments and cures for COVID-19


Why Health Companies Need to Know How the FDA and FTC Enforce Regenerative Medicine Industry Violations

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


Need-to-Know Laws and Regulations for Regenerative Medicine

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


Why Some Healthcare Startups and Practices Succeed While Others Fail: Legal Intel

We’ve counseled hundreds and hundreds of healthcare companies, ventures and practices over the last 30 years. I’d like to talk to you about the difference between what makes a successful [...]


Understand the FDA and other Rules and Regulations for Making CBD Food Products and Supplements

California Department of Public Health (CDPH) does not authorize CBD-infused foods. The Farm Bill does make hemp an agricultural product. The FDA may approve CBD-based drugs through scientific [...]


3 FDA Legal Traps When Marketing your Dietary Supplement Product

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

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