FDA & FTC Regulatory Peril in Consumer Products

In today’s video, let’s talk some more about FDA and FTC issues in consumer products that focus on health, wellness, lifestyle or fitness.


Legal Compliance Issues for American Medical Tourism Health Practices

Physicians who wish to work in the medical tourism sector need to be careful to separate their medical tasks from their business and marketing tasks and to avoid fee-splitting issues

How Does FDA Regulate Direct-to-Consumer Tests

In today’s video, we discuss how FDA regulates direct-to-consumer tests, tests that are marketed directly to consumers without the involvement of a health care professional, like the patient’s [...]


Ambulatory Surgery Center (ASC) Compliance Issues

Ambulatory surgery centers are attractive to doctors and patients due to reduced wait times, better control over infections, and other reasons – provided the ASCs do not violate the AKS or Stark Law.

Who Wants to Be a Physician Pharmacy Owner?

In today’s video, we discuss whether physicians something that many of our physician clients have asked us about, namely, whether they can operate and open their own pharmacies or even have [...]


How Have States Relaxed the Telemedicine Requirement of a Good Faith or Appropriate Prior Exam?

Many states are easing the restrictions on using telehealth during COVID including easing licensing requirements and in-person visit requirements.

Can a Healthcare Product Distributor Get Sued for Repeating a 510(k) Claim That’s False?

In today’s video, we discuss how a distributor of a health and wellness consumer product (it could be you) bought themselves a lawsuit, when they purchased an FDA-registered, Class 1 medical [...]


Additional State Telehealth Waivers During the COVID-19 Pandemic. Part Three.

Many states, such as Illinois, Iowa, Massachusetts, Minnesota, New Jersey, and North Carolina, are easing the restrictions on using telehealth serviced during the COVID pandemic.

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.