The best of two evil.Those that pretend that the FDA is biased have a valid point.
Yes the FDA accept fee from pharma company including Theralase.
But it is a user fee.
It was created in 1992 under the PDUFA act.
Prescription Drug User Fee Act Reauthorization (PDUFA VI), Medical Device User Fee Act Reauthorization (MDUFA IV), Generic Drug User Fee Act Reauthorization (GDUFA II), and Biosimilar User Fee Act Reauthorization (BsUFA II) - 03/21/2017 | FDA Why was it created? Because at the time the FDA was understaffed, unpredictable, and very slow. It also lacked sufficient staff to perform timely reviews.
Unfortunately because the FDA needed the big pharma money in order to survive, it did create a conflict of interest, and in many case, new drugs with low efficacy and unsafe were approved by the FDA, just to get the money the FDA needed to survive.
But the positive side of the PDUFA act, was it did accelerate the approval process of new drugs.
But lately under pressure from the scientific community, doctors, polititiants..etc, the FDA seem to have become more cautious about the safety and efficacy approval of new drugs.
That could in part explain the questioning Theralase is facing on the part of the FDA.
Luckily for us, Ruvidar has the best Duration Of Response and the best safety profile of all the FDA approved and non approved treatments for BCG resistant patients.