Newsletter - July 27, 2023
WHO’s Clinical Trial Guidance: Same Intent as FDA, With a Twist
The ICH E6 guidance document and FDA’s clinical trial guidance contain requirements for good clinical trials, but they do not address practical issues related to the conduct of clinical trials particularly in resource-limited and multi-national settings. All locations where trials are being conducted or planned to be...Read More
FDA Creates a Certification for Foreign Food Suppliers: VQIP
This week, FDA announced the Voluntary Qualified Importer Program (VQIP) primarily designed for foreign food importers to expedite entry of their food products for human and animal consumption in the US. This program will be additional to the Foreign Supplier Verification Program (FSVP) that is required...Read More
WHO’s Clinical Trial Guidance: Same Intent as FDA, With a Twist
The ICH E6 guidance document and FDA’s clinical trial guidance contain requirements for good clinical trials, but they do not address practical issues related to the conduct of clinical trials particularly in resource-limited and multi-national settings. All locations where trials are being conducted or planned to be...Read More
FDA Creates a Certification for Foreign Food Suppliers: VQIP
This week, FDA announced the Voluntary Qualified Importer Program (VQIP) primarily designed for foreign food importers to expedite entry of their food products for human and animal consumption in the US. This program will be additional to the Foreign Supplier Verification Program (FSVP) that is required...Read More