FDA Extends Expiration Dating Of Repackaged Drugs To One Year
This article was originally published in The Pink Sheet Daily
The agency proposes revising a 1984 guideline that provided a six-month maximum expiration date for nonsterile, unit-dose repackaged drugs without additional stability studies. FDA's draft guidance would harmonize enforcement policies on expiration dating with USP standards.
You may also be interested in...
FDA has proposed to tighten proposed limits on the use of oral solid drugs from one year to just six months after they're repackaged into unit doses, except under certain circumstances, in line with USP standards on expiration dating.
FDA is clarifying that it expects sponsors to provide analysis of efficacy data rather than simply a summary of clinical data as part of the integrated summary of effectiveness in new drug applications
Interim data from SHARP and IMPROVE-IT trials fail to show evidence of impact on cancer rates.