Zdrowie i gospodarka · 26/10/2000

FDA Releases Draft Guidance on Referencing Discontinued Labeling for Listed Drugs in ANDA Submissions

The Food and Drug Administration (FDA) has released a draft guidance document titled "Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications" to provide industry guidance on referencing discontinued labeling for listed drugs in ANDA submissions. This issue has recently come to light and is not currently addressed in FDA regulations governing ANDA approvals.