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Phased Review Process

Phased Review Process. Sharon Ricciardo Consumer Safety Officer. Phased Review Basics. Each technical section is submitted independently to appropriate review Division Sponsor receives a technical section complete or incomplete letter from each review Division

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Phased Review Process

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  1. Phased Review Process Sharon Ricciardo Consumer Safety Officer

  2. Phased Review Basics • Each technical section is submitted independently to appropriate review Division • Sponsor receives a technical section complete or incomplete letter from each review Division • After all technical sections are complete submit an administrative ANADA • Can convert to a traditional ANADA at any time but once converted can not switch back.

  3. Technical Sections • Patent Certification and Marketing Exclusivities • Chemistry (CMC) • Environmental Impact • Bioequivalence (BQ) • FOI Summary – CVM Initiated • Labeling

  4. Submission Identifier J-XXXXXX-X-XXXX

  5. CVM Coding • “A” Opening a JINAD File • “B” NCIE • “E” Protocol Review • “M” Minor technical section • “P” Major technical section • “Q” CVM initiated (FOI Summary) • “R” Request for waiver • “X” Environmental • “Z” Request for a meeting (Pre submission conference)

  6. Coding Continued • P submissions – Major Technical Sections • Patent Certification and Marketing Exclusivities • CMC • BQ • Environmental Impact • M submissions – Minor Technical Section • Labeling

  7. Z Request for a meeting The Big Picture Submissions with in vivo study Disclaimer: The sequence of submissions in this example is only an example. Your phased review may take a very different path. Administrative ANADA A submission A X E B P P P P M Q APPROVAL Major Technical Section (Patent & Exclusivities) FOI Summary CVM generates Request For Categorical Exclusion Major Technical Section (Env. Impact) Major Technical Section (BQ) Protocol review Major Technical Section (CMC) Notice of Shipment (NCIE) Labeling Opening a JINAD File All technical sections complete

  8. The Big Picture Submissions with waiver Disclaimer: The sequence of submissions in this example is only an example. Your phased review may take a very different path. Administrative ANADA A submission A X E B P P P P M Q R APPROVAL Request For Categorical Exclusion Major Technical Section (Patent & Exclusivities) FOI Summary CVM generates Major Technical Section (Env. Impact) Major Technical Section (BQ) Protocol review Request for waiver from performing In vivo BQ studies Major Technical Section (CMC) Notice of Shipment (NCIE) Labeling Opening a JINAD File All technical sections complete

  9. Questions?

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