FDA Questions GPhA’s Stability Requests Because of Recall Data

June 5, 2012
FDA statistics show more than one-third of all drug recalls last year were due to stability failures — a figure that suggests the generic industry’s call for stability testing flexibility in a forthcoming guidance is unwarranted, agency officials say. “Scientifically,” it would make sense for ANDA requirements to be less stringent than those for an NDA, Lawrence Yu, deputy director for science and chemistry in the FDA’s Office of Generic Drugs (OGD) said May 23. “But the recall data show otherwise,” Yu said at an FDA/Generic Pharmaceutical Association (GPhA) workshop on generic drug Chemistry, Manufacturing and Controls in Bethesda, Md.
Washington Drug Letter