Newsletter - September 10, 2020
Can the US Government Force Companies to Release Covid Vaccines Early?
A five-year long fraud by one clinical trial company on eight of its clients that was undetected by most till one of the clients got suspicious and complained to the FDA raises concerns about how clinical trials are audited by sponsors. Last month the Department of Justice charged eight individuals in Ohio with several counts...Read More
FDA Has Issued No Warning Letters for GMP Non-Compliance since March
This week CEOs of nine biotech companies publicly pledged that they will not file for FDA approval or emergency authorization for their Covid vaccines unless they meet FDA’s established standards but this pledge may be hard to hold in the current circumstances. It is an odd pledge as it states the obvious;....Read More
Can the US Government Force Companies to Release Covid Vaccines Early?
A five-year long fraud by one clinical trial company on eight of its clients that was undetected by most till one of the clients got suspicious and complained to the FDA raises concerns about how clinical trials are audited by sponsors. Last month the Department of Justice charged eight individuals in Ohio with several counts...Read More
FDA Has Issued No Warning Letters for GMP Non-Compliance since March
This week CEOs of nine biotech companies publicly pledged that they will not file for FDA approval or emergency authorization for their Covid vaccines unless they meet FDA’s established standards but this pledge may be hard to hold in the current circumstances. It is an odd pledge as it states the obvious;....Read More
