Brought into being by the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), the FDA’s pre-ANDA program is designed to accelerate access to generic versions of complex products. The program accomplishes this goal by assisting applicants with the development of more complete submissions, promoting a more efficient and effective ANDA review process, reducing the number of review cycles, and facilitating the approval of complex generic products.
The Three Meeting Types
Pre-ANDA meetings speed up the development of generics through early engagement with the FDA. The program features three types of meetings: Pre-ANDA Product Development meetings (PDEV), Pre-Submission meetings (PSUB), and Mid-Review-Cycle meetings (MRCM).
PDEV meetings are conducted when the product is in its early stages of development. As applicants draft their meeting packages, they should develop a list of questions that may relate to such things as chemistry, manufacturing controls, bioequivalence, or device issues if it is a combination product.
The questions must be specific, and must have sufficient supporting information, so that the FDA can review and provide a meaningful response. The response could be in the form of a written response only where the applicant does not go onsite to have a meeting. If a face-to-face meeting is granted, the applicant will go onsite to the FDA for a one-hour meeting to go through the questions that have been prioritized in the applicant’s meeting package.
If the applicant is granted a PDEV meeting, they will have the opportunity to have a PSUB meeting. The purpose of the PSUB meeting is to go over the content and format of the application as the applicant is close to submitting their application. The PSUB does not include substantive review of the ANDA, rather, FDA will identify items or information that should be clarified prior to submission of the ANDA. If a PDEV meeting is not granted, a PSUB meeting may not be granted. The PSUB meeting is the applicant’s chance to get some early feedback to try to mitigate some potential problems with their application.
Finally, there is the MRCM meeting. This meeting comes after the ANDA has been submitted and is conducted only during the first review cycle, typically 30 days after the mid-point of the review cycle. It cannot be requested by the applicant. This meeting is granted by the FDA if an applicant has had a prior PDEV or PSUB meeting to discuss any issues that they have identified up to that point in their technical review.
Pre-ANDA Meetings are for Complex Products Only
In the new drug world, applicants can get a meeting for every application. However, in the generic world, pre-ANDA meetings are only granted for complex products.
The Office of Generic Drugs defines complex products as those with:
- Complex active ingredients, such as peptides, complex mixtures, or natural source products
- Complex formulations, such as liposomes and emulsions
- Complex routes of delivery, such as locally acting drugs including dermatological products and complex ophthalmological products
- Complex dosage forms, such as transdermal systems and extended release injectables
- Complex drug-device combinations, such as dry powder inhalers and nasal sprays
- Other products where complexity or uncertainty concerning the approval pathway or possible alternative approach would benefit from early scientific engagement
ProPharma Group is Your Pre-ANDA Partner
Preparing for and attending pre-ANDA meetings requires a high level of attention to detail. ProPharma Group is experienced with ushering our clients through this complex process. We can help draft the initial meeting request letter, identify the questions and supporting information, and help write the meeting package. We will also submit the meeting request through the CDER Direct NextGen Collaboration Portal.
To further assist our clients, we will conduct a meeting dry run prior to the date of the meeting. And, we can perform the role of project manager during the actual meeting with the FDA by taking notes and helping move the agenda along. Finally, we conduct a debriefing with our clients to make sure that everything is understood, and prepare meeting minutes which are then provided to OGD.
If you are developing a complex generic product, contact us today for assistance with your pre-ANDA meetings.
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