Newsletter - July 26, 2018
FDA Provides a Path to Use RWE For New Approvals: Highlights Challenges With Doing the Same
Electronic health records (EHRs) provide a rich source of real-world health-related information which can be used as an electronic source data in clinical investigations. However, there are several conditions that one needs to meet before it would be acceptable to FDA. FDA has allowed use of electronic sources data (e-Source) for several years...Read More
FDA Proposes Special Meetings to Discuss New Surrogate Endpoints
This week FDA released a list of all surrogate endpoints used for approval of drugs and created a special meeting specifically to discuss creation of new surrogate endpoints. The list of surrogate endpoints includes more than 100 drug and biologic products approved by FDA over the last 10-15 years and cover practically all major indications. Read More
FDA Provides a Path to Use RWE For New Approvals: Highlights Challenges With Doing the Same
Electronic health records (EHRs) provide a rich source of real-world health-related information which can be used as an electronic source data in clinical investigations. However, there are several conditions that one needs to meet before it would be acceptable to FDA. FDA has allowed use of electronic sources data (e-Source) for several years...Read More
FDA Proposes Special Meetings to Discuss New Surrogate Endpoints
This week FDA released a list of all surrogate endpoints used for approval of drugs and created a special meeting specifically to discuss creation of new surrogate endpoints. The list of surrogate endpoints includes more than 100 drug and biologic products approved by FDA over the last 10-15 years and cover practically all major indications. Read More
