US FDA’s Pre-ANDA Advice On Correspondence, Meetings And Product-Specific Guidance
OGD's Lionberger offers advice on when to request a pre-ANDA meeting instead of controlled correspondence – and on the pros and cons of waiting for the agency to update product-specific guidance with the latest approaches.
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Complex Generics: US FDA Heeds Some, But Not All, Of Industry’s Calls For Flexibility On Transdermal Products
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US FDA Commits To Meeting With Complex ANDA Sponsors, Works Hard To Avoid It
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