Day: July 19, 2018

In a review of 46 drugs approved under the breakthrough therapy (BTD) program, it was found, not surprisingly, that most of the approvals were based on smaller, uncontrolled clinical trials, implying that the BTD programs leads to approval of unsafe drugs. However, this analysis ignores the core premise of this program, namely faster approval for … Read more

Serving on the FDA Advisory Committees is a considered a very prestigious accomplishment for most academic and professional experts who help FDA make tough decisions about new drugs. A survey of the post-Advisory Committee life of these experts found that for many, this also serves as an attractive credential for companies seeking to hire expert … Read more