17 Jan 2023
FDA Administrative Decision Challenges
Obtain guidance on challenging adverse Food and Drug Administration (FDA) administrative decisions. This practice note includes strategies for obtaining a final agency decision that can be challenged in court, overcoming agency deference challenges, and selecting a jurisdiction.
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- FDA Complete Response Letters
Be prepared to respond to an FDA-issued complete response letter (CRL). A CRL is a material, reportable event for public companies, and potentially devastating for nonpublic companies that have staked their reputation on the FDA’s approval or licensing of a particular drug product.
- Life Sciences Regulatory Enforcement Resource Kit
Find materials including trackers, practice notes, state law surveys, and articles for navigating the highly regulated life sciences industry.
- FDA Warning Letters Tracker
Monitor warning letters issued by the FDA in response to FDA’s determination that a manufacturer has violated, or potentially violated, applicable requirements of the Food, Drug, and Cosmetics Act (FDCA), FDA regulations, or agency guidance.
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