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FDA Uses Biosimilar Strategy For Complex Generics, Offers Pre-ANDA Meetings

 
• By Derrick Gingery

Meetings must have specific topics, and may not always be granted, but are available to sponsors to gain advice on moving forward with complex products.

FDA’s Office of Generic Drugs appears to be taking a page from the biosimilars playbook in encouraging pre-submission meetings for complex generics to potentially encourage more sponsor interest and improve submission quality.

Meetings will not always be granted, and likely are not needed for most ANDAs, but the agency said it is...

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