Newsletter - September 15, 2022
Importance of Cover Letters in Directing FDA Staffs’ Review of Applications
IND, NDA and BLA submissions containing real-world data and real-world evidence (RWD/RWE) should highlight that info in the cover letter to that submission, according to the latest FDA guidance on best practices for the using such data to support claims in an application. While the guidance may seem...Read More
FDA Recommends Risk-Based Approach for Software Quality Assurance
Validation of software used in manufacturing processes such as for automation or quality control functions should not only be validated prior to use, but also follow a life cycle testing program to maintain an acceptable level of assurance of quality performance. Basically, FDA expects a similar life-cycle approach...Read More
Importance of Cover Letters in Directing FDA Staffs’ Review of Applications
IND, NDA and BLA submissions containing real-world data and real-world evidence (RWD/RWE) should highlight that info in the cover letter to that submission, according to the latest FDA guidance on best practices for the using such data to support claims in an application. While the guidance may seem...Read More
FDA Recommends Risk-Based Approach for Software Quality Assurance
Validation of software used in manufacturing processes such as for automation or quality control functions should not only be validated prior to use, but also follow a life cycle testing program to maintain an acceptable level of assurance of quality performance. Basically, FDA expects a similar life-cycle approach...Read More
