FDA Takes Prudent Tact In Response To Endo Compounding Lawsuit

FDA appears to be framing its policy on compounding of bulk substances by outsourcers differently to the courts than it is to Congress, one compounding attorney commented after reading the agency response to a lawsuit seeking to block FDA's interim policy on 503B compounding. However, multiple sources opined that FDA's decision not to defend its current policy on the merits, but rather attempt to get the case thrown out on procedural grounds, is likely a litigation tactic. As Inside Health...