Day: September 21, 2023

There have been numerous controversial decisions by the FDA in recent years where it approved new drugs despite its Advisory Committees (AdCom) recommending against it. But the FDA, being an equal opportunity disagreer, at times also rejects drugs that were recommended by its AdCom for approval as was shown this week when it rejected an … Read more

Although traditional FDA approval for a new drug or biologic requires evidence from two or more clinical trials, it is possible for the FDA to approve new products based on evidence from a single clinical trial under certain conditions. A new FDA Guidance Document released this week describes these conditions. The law provides the FDA … Read more