Can the Federal Trade Commission File Complaints Against Businesses That Target Consumer Locations Without the Consent of the Consumer?
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
How Developers Can Benefit from the FDA’s Center for Devices and Radiological Health (CDRH) New Innovation Policies
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
FDA Grants Accelerated Approval for a New Alzheimer’s Disease Treatment
The FDA recently approved the drug, of Leqembi, a treatment of Alzheimer’s disease, through the accelerated approval process.
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.
Legal Compliance Issues for Integrative Cardiology
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 [...]
HIPAA and Access. Legal Summary and Recent Investigations
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.
Relaxing Vaccine Dosage and Food Label Requirements
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 and Johnson’s COVID-19 Vaccine Should Be Reviewed by FDA Soon
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 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
3 Ways Marketing Claims Can Destroy Healthcare Companies: FTC, Plaintiff Trolls, & State Regulatory Agencies
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.
Why Medical Device Companies Need to Fear FDA Warning Letters
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 [...]
September 2020 FDA Warning Letters
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 Warning Letters Can Cause Cosmetic Companies to Lose Revenue and Face Substantial Fines
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
Red Flags that Leads to FDA Warning Letters
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 [...]
Medical Tourism Model can raise FDA and FTC Legal Issues
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 CBD Oil Business Case Study
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 [...]
