Anavex Life Sciences Corp (AVXL)

[kevli33]

Delivering Promising New Medicines Without Sacrificing Safety and Efficacy
All drugs approved under the agency’s expedited programs are held to the same approval standards as other FDA drug approvals.

FDA is charged with regulating new medicines, including novel ones like cell and gene therapies, and we make decisions about whether these can be marketed. We apply the same statutory standards for safety and efficacy to all new medicines, but the overall benefit-risk evaluation, and the clinical trial programs, vary depending on the circumstances. For fatal diseases without available treatments, the risk of more significant side effects may be acceptable. For rare diseases, we can’t expect very large trials. For potentially fatal diseases with existing life-saving treatments, we expect new therapies to be as good or better than those already approved, or to decrease the significant side effects. For conditions like high cholesterol that have a lot of therapies available for their treatment, we expect new drugs to be very safe.

https://www.fda.gov/news-events/fda-voices-perspectives-fda-leadership-and-experts/delivering-promising-new-medicines-without-sacrificing-safety-and-efficacy