The FDA asked for comments on a pilot program that would review the toxicology and quality of novel excipients outside of drug applications.
The agency has not previously assessed the safety of novel excipients except as part of INDs, NDAs and BLAs. The planned pilot would review several submissions for novel excipients per year.
Novel excipients could improve drug delivery or abuse-deterrence, but the safety concerns that novel excipients currently bring up during agency reviews discourage their use in drug development programs.
Before the agency decides whether to develop the program, it wants to learn more about the drug development challenges sponsors face that the use of novel excipients could address. It also wants to hear about examples of novel excipients with potential public health benefits.