BIO Comments to FDA (No. FDA–2022-D-2983) Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
May 2, 2023
BIO submitted comments and recommendations to FDA on their Draft Guidance on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.
Download Full Comments Below
BIO Comment Letter Consideratins Externally Controlled Trials FDA 2022
BIO’s comments support accelerated approval as an important regulatory pathway that allows patients with serious and life-threatening illnesses such as cancer to have earlier access to promising therapies.
BIO submitted comments and recommendations to FDA on their Draft Guidance on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.