Newsletter - April 27, 2023
FDA Clarifies Electronic Submission of Veterinary Product Applications
The Center for Veterinary Medicine (CVM) at the FDA has been accepting applications for new products electronically for a few years. But since CVM applications and documents follow a very different format compared to those for the human drugs and biologics, it has been confusing for companies to understand...Read More
EMA Describes Considerations for Single-Arm Studies for Oncology Drugs
More than half of the cancer drugs are approved by the FDA based on non-randomized single-arm trials using surrogate endpoints. Also, many drugs for ultra-rare diseases with few or no options are approved based on open-label studies since including a placebo or a standard of care control arm is not feasible...Read More
FDA Clarifies Electronic Submission of Veterinary Product Applications
The Center for Veterinary Medicine (CVM) at the FDA has been accepting applications for new products electronically for a few years. But since CVM applications and documents follow a very different format compared to those for the human drugs and biologics, it has been confusing for companies to understand...Read More
EMA Describes Considerations for Single-Arm Studies for Oncology Drugs
More than half of the cancer drugs are approved by the FDA based on non-randomized single-arm trials using surrogate endpoints. Also, many drugs for ultra-rare diseases with few or no options are approved based on open-label studies since including a placebo or a standard of care control arm is not feasible...Read More
