Newsletter - September 21, 2023
Market Approval Based on a Single Clinical Trial is Possible, But…: FDA
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. Read More
FDA Rejects AdCom Recommendation for Approval of Nasal Epinephrine Spray
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...Read More
Market Approval Based on a Single Clinical Trial is Possible, But…: FDA
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. Read More
FDA Rejects AdCom Recommendation for Approval of Nasal Epinephrine Spray
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...Read More
