What are the steps involved when a dossier (ANDA) is submitted to the agency (US FDA)?
When a dossier, specifically an Abbreviated New Drug Application (ANDA), is submitted to the regulatory agency like the U.S. Food and Drug Administration (FDA), a comprehensive review process takes place. Here are the general steps:
1. Document Verification: The agency checks the submission for completeness and whether it meets the required format and standards.
2. Administrative Review:The application goes through an administrative review to ensure it contains all necessary forms and fees.
3. Filing Review: During this phase, the agency reviews the ANDA to determine if it can be filed for review. If there are any major deficiencies, the application may be rejected (RTR), and the applicant may be asked to resubmit.
4. Substantive Review: Once the application is filed, the agency conducts a substantive review. This involves a thorough evaluation of the data and information provided in the dossier, including the drug’s chemistry, manufacturing, controls, bioequivalence, labeling, and more.
5. Deficiency Letter (if applicable): If the agency finds any issues or gaps in the submitted data, a deficiency letter is issued to the applicant, specifying the additional information or clarification required.
6. Applicant Response: The applicant responds to the deficiency letter by providing the requested information or addressing the concerns raised by the agency.
7. Review Continuation: If the agency finds the response satisfactory, the review process continues.
8. Approval or Denial: After a comprehensive evaluation and considering any public health concerns, the agency decides whether to approve or deny the ANDA. If approved, the generic drug can be marketed and sold in the market as a substitute for the brand-name drug.
