Newsletter - May 4, 2017
Using Foreign Vendors? FDA’s Warning Letter Points A Common Issue
This week FDA released a Warning Letter* issued to a GMP vendor in India that points to a very important issue that all companies using vendors, specifically foreign vendors, should be aware of, namely, who is listed as the manufacturer on the Certificate of Analysis (COA). Read More
FDA and NIH Release the Best Free Tool to Write Clinical Protocols
Clinical trial populations are not very diverse. Minority populations form a very small fraction of the trial populations, much below their proportion in the US population leading to concerns about the effectiveness of approved products in populations under-represented in clinical trials. Read More
Using Foreign Vendors? FDA’s Warning Letter Points A Common Issue
This week FDA released a Warning Letter* issued to a GMP vendor in India that points to a very important issue that all companies using vendors, specifically foreign vendors, should be aware of, namely, who is listed as the manufacturer on the Certificate of Analysis (COA). Read More
FDA and NIH Release the Best Free Tool to Write Clinical Protocols
Clinical trial populations are not very diverse. Minority populations form a very small fraction of the trial populations, much below their proportion in the US population leading to concerns about the effectiveness of approved products in populations under-represented in clinical trials. Read More
