Immunotherapy and Healthcare Compliance
Immunotherapy drugs are showing promise for treating cancer. Manufacturers of these therapies and doctors must understand the FDA, HIPAA, and other compliance requirements.
FDA Laws and Regulations About The Metaverse
Many metaverse augmented reality, virtual reality, artificial intelligence, and other med-tech applications will need to meet FDA medical device requirements.
Adaptogens and FDA/FTC Compliance
Many companies are making and selling products with herbs and other adaptogens that claim to relieve stress and need to understand the FDA regulations that regulate drugs and dietary supplements.
Legal Compliance Issues for Homeopathy
Homeopathic medicine is an alternative medical practice that appeals to millions of people. Anyone involved with the practice of homeopathy needs to understand FTC compliance issues.
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.
7 Legal Keys to Getting Your OTC Drug to Market
Wondering how to get your OTC drug to market? This FDA OTC drug primer tells you how.
Study: Scientifically Unproven Marketing Claims Very Common on Websites
Michael H Cohen has been interviewed by the Medical Ethics Advisor, a well established publication that focuses on current healthcare issues.
FDA Mobile Medical App Guidance Reads FDA Medical Jurisdiction Expansively
The FDA's Mobile Medical App Guidance contains many nuanced definitions that determine whether your mobile app will likely be regulated by the FDA as a medical device.Recent clients have asked [...]
Michael H. Cohen Speaking on FDA & Related Legal Issues in Online Health Ventures
Attorney Michael H. Cohen speaks on "FDA & Related Legal Issues in Online Health Ventures" at a prominent LA law firm's Restaurant, Food & Beverage Group on July 9.
Mobile App Developers Can Be Slammed by FTC or FDA
The Federal Trade Commission (FTC) requires that advertising be truthful and not misleading, and will take enforcement action if mobile app developers make deceptive claims about their apps.
LARTA Commercialization Assistance Program
Michael H. Cohen participated in the LARTA Commercialization Assistance Program in Los Angeles (April 2013), sponsored by the National Institutes of Health, as a mentor to provide guidance to [...]
