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Complex ANDAs: Early Meetings With FDA Can Generate Bonus Communication

 
• By Derrick Gingery

By conducting a product development or pre-submission meeting, sponsors can receive a mid-review cycle meeting for a complex product ANDA.

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FDA outlines formal meeting process for sponsors of complex generic drugs.

Developers of complex generics will gain additional communication rewards if they follow FDA's formal meeting pathway.

Newly released guidance on formal meetings for complex product ANDAs outlines how and when product development, pre-submission, and mid-review cycle meetings are available

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