Newsletter - March 21, 2024
FDA Dings Medical Device Trial for Lack of IRB Review and Monitoring
A medical device company had to suspend its ongoing pivotal clinical trial and may lose the data collected in the trial so far because of major violations of Good Clinical Practices (GCP) found during an FDA audit. The Warning Letter issued to the company looks like a lesson in the basics of GCP compliance...Read More
The Impact of the US Law Banning WuXi on its US Customers
For the last few months, a new Law, called the Biosecure Act, has been gaining bipartisan support in the US Congress, which aims to ban business with Chinese biotech companies, the biggest of them WuXi companies. The law could have some serious consequences for the US customers of these companies...Read More
FDA Dings Medical Device Trial for Lack of IRB Review and Monitoring
A medical device company had to suspend its ongoing pivotal clinical trial and may lose the data collected in the trial so far because of major violations of Good Clinical Practices (GCP) found during an FDA audit. The Warning Letter issued to the company looks like a lesson in the basics of GCP compliance...Read More
The Impact of the US Law Banning WuXi on its US Customers
For the last few months, a new Law, called the Biosecure Act, has been gaining bipartisan support in the US Congress, which aims to ban business with Chinese biotech companies, the biggest of them WuXi companies. The law could have some serious consequences for the US customers of these companies...Read More
