‘ANDA Labeling: Frequently Asked Questions’ Whitepaper

The rapidly evolving regulatory landscape coupled with accelerated introduction of new reforms and guidelines for pharmaceutical labeling industry in the past few years, demand companies to be pro-active in terms of their implementation lifecycles. In this whitepaper, we look to provide our answers as well as recommendations on some of the most frequently asked questions regarding ANDA labeling.

The ‘ANDA Labeling: Frequently Asked Questions’ Whitepaper addresses generic drug labeling issues such as:

• Official source to obtain RLD labeling
• Way forward when the RLD is discontinued or withdrawn
• RLD updates
• Applicability of electronic Medication Guides
• Removal of Pregnancy Category

The brief whitepaper also provides important labeling tips on USP compliance statements, CRP requirements and revision dates.

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