Generic inactive ingredient policy expected to be completed by early 1998, OGD's Johnston predicts.
Executive Summary
OGD INACTIVE INGREDIENT POLICY TO BE COMPLETED BY EARLY 1998, FDA Office of Generic Drugs Deputy Director Gordon Johnston predicted at a Sept. 10 session of the Regulatory Affairs Professional Society conference in Washington, D.C. "I am sure it's going to be several months, but I would hope in 1998 we will have a guidance out to industry," Johnston said. "The 1994 interim active ingredients policy that we have been operating under is probably short lived at this time," he commented, adding that the interim reg is being reviewed by a working group.