FDA Extends Stem Cell Enforcement Discretion, With a Heavy Heart 

This week FDA announced that it has extended its enforcement date for illegal stem cell clinics by six months due to the pandemic. At the same time, FDA released a blog targeted towards patients telling them about the dangers of the illegal stem cell therapies, and a final guidance document reiterating FDA’s policies that almost … Read more

Employees in Clinical Trials Boost or Bust the Prospects of a Company? 

Sinopharm, the Chinese government owned company announced that 30 of its employees, including some in senior management roles, were the first to receive its experimental Covid vaccine. And this would be legal even in the US. It is often assumed, incorrectly, that the regulations prohibit employee participation in company-sponsored clinical trials. On the contrary, under … Read more