what is the difference between 505j and 356h?

The difference between 505(j) and 356(h) lies in their purposes, regulatory pathways, and application forms in the context of the U.S. Food and Drug Administration (FDA) drug approval processes:

505(j) – Abbreviated New Drug Application (ANDA)

• Purpose: This is the regulatory pathway for generic drugs.
• Key Features:
  • Used for drugs that are bioequivalent to an already approved Reference Listed Drug (RLD).
  • Requires no clinical trials for safety and efficacy but must demonstrate bioequivalence.
  • Focuses on equivalence in active ingredient, dosage form, route of administration, strength, and labeling (with some exceptions).
  • Governed by the Hatch-Waxman Act.
• Submission Form: Typically submitted as part of an ANDA, but the form used is FDA Form 356h (as a common submission form across drug applications).

356(h) – Application Form

• Purpose: FDA Form 356h is the standardized application form used to submit various types of drug applications to the FDA.
• Key Features:
  • It is not specific to a regulatory pathway like 505(j) or 505(b).
  • Can be used for:
    • New Drug Applications (NDAs) [e.g., 505(b)(1)]
    • Abbreviated New Drug Applications (ANDAs) [e.g., 505(j)]
    • Biologics License Applications (BLAs) [e.g., biologics under the Public Health Service Act].
  • Contains administrative information about the submission, applicant, drug product, and certification.

Key Differences:

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In summary, 505(j) refers to the regulatory pathway for generic drugs, while 356(h) is a form used for submitting various types of drug applications, including those under the 505(j) pathway.