Home » Sponsor Data Must Support Need for Excess Drugs in Injectable Products
Sponsor Data Must Support Need for Excess Drugs in Injectable Products
The FDA is asking sponsors of ANDAs, BLAs and NDAs to justify the amount of excess medication they plan to pack in vials and ampules of injectable drug products. Under the U.S. Pharmacopeia (USP), makers of injectables are asked to provide medication that “slightly exceeds” the amount indicated on the drugs’ labeling.
Generic Line
Drugs Quality Regulatory AffairsGeneric Line
Upcoming Events
-
04Apr
-
11Apr
-
14Apr
-
25Apr
-
14May