Draft Guidance for Industry on Stability Testing of Drug Substances and Drug Products; Availability; Extension of Comment Period

概要

The Food and Drug Administration (FDA) is extending to December 8, 1998, the comment period for the draft guidance for industry entitled ``Stability Testing of Drug Substances and Drug Products.'' The draft guidance provides recommendations regarding the stability studies that should be performed to support new drug applications (NDA's), abbreviated new drug applications (ANDA's), investigational new drug applications (IND's), biologics license applications (BLA's), product license applications (PLA's), and supplements to these applications. FDA published a notice of availability of the draft guidance in the Federal Register of June 8, 1998 (63 FR 31224). FDA is taking this action in response to several requests for an extension. DATES: Written comments on the draft guidance may be submitted by December 8, 1998. General comments on the draft guidance are welcome at any time.