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Regulatory Submissions and Compliance Flashcards

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  1. Which regulatory submission to the FDA requires GLP-compliant nonclinical safety data as a prerequisite for approval?

    Answer: New Drug Application (NDA) and Investigational New Drug Application (IND)

    Both IND and NDA submissions require GLP-compliant nonclinical safety data to support human exposure and marketing approval.

  2. What must a sponsor include in an IND submission regarding GLP compliance of nonclinical studies?

    Answer: A statement indicating whether each study was conducted in compliance with GLP and an explanation if not

    The IND must include a statement for each nonclinical study indicating GLP compliance status and justification for any non-compliance.

  3. Which FDA center is responsible for issuing GLP inspection citations for pharmaceutical nonclinical studies?

    Answer: FDA's Bioresearch Monitoring (BIMO) program within CDER and CBER

    FDA BIMO programs within CDER and CBER conduct GLP inspections and issue citations for pharmaceutical nonclinical studies.

  4. What is the consequence of a GLP inspection finding that results in an FDA Form 483 issuance?

    Answer: The form lists inspectional observations that must be addressed by the facility with a written response

    FDA Form 483 documents inspectional observations that require a formal written response from the facility management.

  5. Which action by the FDA represents the most serious enforcement outcome following a GLP inspection?

    Answer: Issuance of a Warning Letter citing GLP violations

    An FDA Warning Letter is the most serious pre-legal enforcement action, indicating significant GLP violations requiring immediate correction.

  6. Under 21 CFR Part 58, which action may the FDA take when a nonclinical study is found to not have been conducted in accordance with GLP?

    Answer: Disqualify the data from the study for consideration in the support of any application for a research or marketing permit

    Non-GLP compliant study data may be disqualified for regulatory consideration, meaning it cannot be used to support applications.

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