Newsletter - February 22, 2018
FDA Expects GCP Compliance from all Medical Device Trials
This week FDA finalized a rule originally proposed exactly five years ago to the date that makes it mandatory for all clinical trials conducted with new medical devices to be compliant with GCP rules similar to those for drugs and biologics. Although the notification refers to non-US clinical trials, but the details of the rule make it clear that this rule applies to trials.. Read More
FDA Explains the Pre-RFD Process for Combination Product Designation
Sponsors looking to get semi-formal advice from FDA regarding which laws apply to their product; drug, device or biologic, got some help from FDA last week with the release of a new guidance about the pre-request for designation (pre-RFD) process. The RFD process that has been in existence for 15 years is run by the Office of Combination Products (OCP).. Read More
FDA Expects GCP Compliance from all Medical Device Trials
This week FDA finalized a rule originally proposed exactly five years ago to the date that makes it mandatory for all clinical trials conducted with new medical devices to be compliant with GCP rules similar to those for drugs and biologics. Although the notification refers to non-US clinical trials, but the details of the rule make it clear that this rule applies to trials.. Read More
FDA Explains the Pre-RFD Process for Combination Product Designation
Sponsors looking to get semi-formal advice from FDA regarding which laws apply to their product; drug, device or biologic, got some help from FDA last week with the release of a new guidance about the pre-request for designation (pre-RFD) process. The RFD process that has been in existence for 15 years is run by the Office of Combination Products (OCP).. Read More
