FDA launched stealth drug testing op
Although India's drugmakers may feel as though they are under regulatory attack, a stealth FDA generic drug testing program indicates the agency is taking an across-the-board assessment of non-branded medications that surface in US markets. Bloomberg reports that the $20-million program, which consists of grants to several institutions, started in September “without any public notice” and will run through 2017.
The four-year program is a significant boost to testing which the FDA has generally done only on occasion and when finances allow for it. Bloomberg reports that the acting director of the FDA's generics division put the agency's budget for generics testing at around $2 million to $3 million, when talking about reviews and resources at the Generic Pharmaceutical Association annual meeting. She said new fees have allowed the agency to pursue generics testing in this more robust manner.