ICH Harmonized Global Stability Testing Recommendations Sought By PhRMA
Executive Summary
The Pharmaceutical Research & Manufacturers of America and the European Federation of Pharmaceutical Industries Associations have convened a working group to establish harmonized global stability testing recommendations for drug products across climatic zones
You may also be interested in...
Stability testing guidance gets stickier
FDA's 1revised guidance on stability testing of drug products raises the relative humidity recommendation for "general case" intermediate storage from 60% to 65%. The change "is intended to harmonize the intermediate storage condition for [climatic] zones I and II with the long-term condition for zones III and IV," FDA says. The Pharmaceutical Research & Manufacturers of America had been pressing for the modification to the 2001 guidance (2"The Pink Sheet" Jan. 6, 2003, p. 20)...
Stability testing guidance gets stickier
FDA's 1revised guidance on stability testing of drug products raises the relative humidity recommendation for "general case" intermediate storage from 60% to 65%. The change "is intended to harmonize the intermediate storage condition for [climatic] zones I and II with the long-term condition for zones III and IV," FDA says. The Pharmaceutical Research & Manufacturers of America had been pressing for the modification to the 2001 guidance (2"The Pink Sheet" Jan. 6, 2003, p. 20)...
FDA Will Accept Common Technical Document Instead Of NDA In July 2001
FDA will begin accepting drug applications in the Common Technical Document format presented as early as July 2001.