FDA CMC Reviewer Recommendations for New Drug Approval Depend on Control Strategy Understanding, CDER is Stressing

CDER is stressing that a clear picture of the control strategy is pivotal for CMC reviewers to make a meaningful application approval recommendation and meet the shrinking timelines under which they are operating.

Providing the reviewer’s vantage point at a DIA CMC Workshop in mid-April in Bethesda, Maryland, Office of Pharmaceutical Quality (OPQ) Office of New Drug Products (ONDP) Acting Director Sarah Pope Miksinski highlighted the challenges of finding and understanding an applicant’s control strategy and why it is important to do so.

The elements of the control strategy can appear throughout the application, she explained, making it difficult for reviewers to put the pieces together. To facilitate the process, the applicant needs to provide cross references and links to make sure the full story is conveyed.

Pointing out that ONDP reviews the CMC section of the application and makes an approval recommendation to the Office of New Drugs (OND), Miksinski stressed that “we need to make that a meaningful recommendation. It oftentimes has to be interpreted by people who do not necessarily understand what a control strategy is.”

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