FDA Form 356h, officially titled "Application to Market a New or Abbreviated New Drug or Biologic for Human Use", serves as a cover sheet for your regulatory submission. It provides the FDA with a snapshot of your application, including applicant details, submission type, and supporting documents.
Key Requirements Before Filling Form 356h
1. Establish an eSubmitter Account: Ensure you’re registered with the FDA’s Electronic Submissions Gateway (ESG) for electronic filings.
2. Determine Your Submission Type: Is it an NDA, ANDA, or BLA? This determines the specific requirements for your application.
3. Compile Your Application Components: Prepare documents like:
- Cover letter
- Formulation and manufacturing details
- Clinical and preclinical study data
- Labeling information
- GMP compliance evidence
Steps to Fill Form 356h
General Information:
- Include your application type and reason for submission (e.g., new application, amendment, supplement).
Applicant Information:
- Provide details of the applicant (company name, address, contact Information).
- Identify the U.S. Agent if the applicant is outside the U.S.
Drug or Biologic Details:
- Specify product name, dosage form, strength, and route of administration.
- Include the Drug Master File (DMF) number if applicable.
Submission Content Details:
- Clearly indicate what is included (e.g., modules of the CTD format, labeling, risk management plans).
Signature & Certification:
- Certify the accuracy of the submission and sign the form.
Tips for a Successful Submission
1. Follow eCTD Guidelines: The FDA prefers applications in the electronic Common Technical Document (eCTD) format.
2. Ensure Completeness: Missing sections can delay your review process. Use the FDA’s checklist to verify completeness.
3. Cross-Check Regulatory Compliance: Ensure your submission complies with 21 CFR requirements.
Conclusion
Form FDA 356h is more than a simple cover page—it’s your gateway to FDA review. A well-prepared form not only demonstrates professionalism but also streamlines the review process.
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