FDA probe looks into unauthorized herpes vaccine research
The criminal investigation examines research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine.
A ‘rogue’ clinical trial for herpes vaccine highlights the risks of flouting FDA regulations
"This researcher went rogue," said Fernandez Lynch, the lawyer who specializes in medical ethics. "When one of their own goes rogue, a university should launch an aggressive investigation, interview the participants and make sure it never happens again."
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
St. Kitts and Nevis officials investigate Rational Vaccines over herpes vaccine clinical trial
The government officials contend that researchers did not officially seek permission for the trial, which took place from April to August 2016.
An offshore clinical trial for herpes vaccine tests new regulatory landscape
Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing of a vaccine its creators say prevents herpes outbreaks.
Rational Vaccines: A case study in pharma deregulation
The FDA does more than screen for drug safety and efficacy; it also protects the public against sensational and unproven claims. It's a reality underscored by an intriguing herpes vaccine company charting its own regulatory course.