1. Pre-ANDA Meeting Request:
This is a request for a meeting with the FDA before submission to discuss any potential issues and guidance on the ANDA process.
2. Bioequivalence Study Data:
This includes all data proving that the generic product is bioequivalent to the reference listed drug (RLD).
3. Labeling Compliance:
The proposed labeling must be reviewed to ensure it is in compliance with FDA regulations and similar to the RLD.
4. Chemistry, Manufacturing, and Controls (CMC) Information:
Detailed information on the composition, manufacture, and quality control of the drug product must be provided.
5. Patent Certification:
The applicant must certify that the proposed generic drug does not infringe on any patents or detail any intended challenges to such patents.
6. Drug Master File (DMF) References:
References to any DMFs must be included, which provide detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of drugs.
7. Environmental Assessment:
An assessment to determine if the proposed action will significantly affect the quality of the human environment.
8. GMP (Good Manufacturing Practice) Certification:
Evidence must be provided to confirm that the manufacturing facilities comply with GMP standards.
9. User Fee Cover Sheet:
A completed form that accompanies the payment of the required user fee for the ANDA submission.
10. Electronic Common Technical Document (eCTD) Format:
The ANDA must be submitted in an eCTD format, which is the standard structure for electronic submissions.