
FDA Releases Guidance on Resolving Issues with the Agency
The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.
On October 11, 2017, FDA published
ANDA applicants may sometimes disagree with FDA regarding scientific or regulatory issues that are an important part of product evaluation. The agency states in the guidance that it is “critical” to have policies and procedures to consider the concerns of applicants. The guidance formalizes FDA’s current and past practices as a way to promote fair and quick resolution of these disputes.
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