Home > Newsletters > Drug Industry Daily > FDA Calls for Six Months of Stability Testing Data for ANDA Filers
Drug Industry Daily
Sept. 25, 2012 | Vol. 11 No. 188
FDA Calls for Six Months of Stability Testing Data for ANDA Filers
Generic-drug makers filing ANDAs and drug master files should provide six months of stability testing data, including accelerated and long-term conditions, and data from three pilot scale batches, or two pilot batches and one small scale batch, the FDA’s Office of Generic Drugs (OGD) says in new draft guidance on stability testing.
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.