Pre-ANDA Program for Complex Generic Products
Complex generic products are in general more challenging than non-complex generic products to develop due to their complex nature. As part of Generic Drug User Fee Amendments (GDUFA) II (started in FY 2018), the FDA committed to developing a program, the Pre-ANDA Program, around complex generic products to assist ANDA applicants and prospective applicants before they submit an ANDA to the FDA. The Pre-ANDA Program is designed to assist prospective generic drug applicants in developing more complete submissions, promote a more efficient and effective ANDA review process, reduce the number of review cycles, and facilitate approval of complex generic products. The Pre-ANDA Program for complex generic products includes: GDUFA science and research, product-specific guidances (PSG), Pre-ANDA meetings, and controlled correspondence.
ANDA applicants and prospective applicants can take advantage of the following resources:
- GDUFA Science and Research
Under the Science and Research program established under the GDUFA, FDA creates an annual list of regulatory science initiatives on generic drugs in collaboration with industry and the public. The research studies conducted under these initiatives advance public health by contributing to the development of safe and effective generic drugs. The results provide new tools for FDA to evaluate generic drug equivalence and for industry to efficiently develop new generic products. During GDUFA II, the priority initiatives are organized according to the categories of complex generic drug products described in the GDUFA II Commitment Letter, followed by a category addressing topics related to tools and methodologies for evaluating bioequivalence and therapeutic equivalence more generally. Research outcomes are being used to support guidance development and regulatory decision making.
- Product-Specific Guidances
Product-specific guidances identify the most appropriate methodology for developing generic drugs and generating evidence needed to support generic approval. New and revised PSGs are published regularly.
- Pre-ANDA Meetings
ANDA applicants for complex generic drug products can request product development or pre-submission Pre-ANDA meetings to help clarify regulatory expectations early in product development (see guidance for industry). If applicants had product development or pre-submission meetings with the FDA, they are also qualified to have a mid-review cycle meeting during application review. Applicants can submit Pre-ANDA meeting requests and supporting documents, such as meeting presentation materials, through the CDER Direct NextGen Collaboration Portal. For questions about submitting Pre-ANDA meeting requests, please contact PreANDAHelp@fda.hhs.gov. Additional assistance is available at:
- Controlled Correspondence
ANDA applicants can submit written inquiries to FDA to request information on a specific element of generic drug development or certain post-approval submission requirements.
- Inactive Ingredient Database
The Inactive Ingredient Database provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products.