NDA Submission 101: Anticipating Study Requirements Early

The following blog details the process of NDA submission and acts as your ultimate guide to a successful submission.

The 1938 Food, Drug, and Cosmetic Act directed the FDA to oversee the review, approval, and oversight of drugs that are marketed in the US. Today, getting FDA approval of a new drug application (NDA) involves years of dedication and clear, accurate data demonstration of the safety and efficacy of a drug.

According to the FDA, an NDA “tells the full story of a drug”¹. In other words, a complete application includes all data on the drug, from preclinical research through Phase 3 clinical trials. The data must clearly demonstrate that the drug is safe and effective for its intended use.

Before submitting an NDA, there are some activities that applicants need to perform:

• Proprietary name submission²: Choosing a proprietary name requires some thought. The drug’s name needs to clearly identify and differentiate the drug. If the name is too similar to another drug on the market, the FDA may deny it.
• Establishment registration³: Before an NDA can be submitted, the drug manufacturer must be registered with the FDA. Working with a CRO can be a huge help here, since CROs update their registration with the FDA annually and are equipped to facilitate the NDA pre- and post-submission testing and manufacturing.
• Pre-submission meeting request⁴: The FDA recommends that applicants request a formal NDA pre-submission meeting 4-6 months before the expected submission date. Pre-submission meetings are voluntary, but they are a valuable opportunity to ask questions and solicit FDA feedback prior to submission.

These pre-submission steps highlight an important part of a successful NDA: consistent communication with the FDA. They can provide clarification on any step of the drug discovery process, from preclinical research to the NDA submission. The best way to avoid mistakes and repeated review cycles is to communicate with the FDA early and often.

Working with an experienced CRO can smooth the application process. Not only will they ensure that every experiment was performed according to FDA regulations, but their statistics experts understand the 135 pages of FDA guidelines for the clinical and statistical components of an NDA. CROs understand the complexities of the approval process and will deliver a complete, clear, and accurate NDA on the first submission.

Once an NDA is submitted, the FDA has 60 days to decide whether to file an NDA for review or reject the application. If it is filed for review, the Center for Drug Evaluation and Research (CDER) will provide a response within six to ten months. If the FDA determines that the benefits of the drug outweigh the risks, NDA approval is given. If a drug is not approved, the FDA will send a complete response letter to the sponsor and applicant⁵. This can be a huge setback, so it’s important to submit an NDA that is clear, comprehensive, and accurate.

Ready to Begin?

To learn more about navigating the complex NDA process, watch the on-demand webinar, “Reading Regulators’ Minds: Avoiding NDA Approval Delays.” Contact us today to learn how we can help you.

References

1. FDA. Step 4: FDA Drug Review. 2018 [cited 2020 April 19]; Available from: https://www.fda.gov/patients/drug-development-process/step-4-fda-drug-review.
2. FDA. Contents of a Complete Submission for the Evaluation of Proprietary Names. 2016 [cited 2020 April 4]; Available from: https://www.fda.gov/media/72144/download.
3. FDA. Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers. 2019 [cited 2020 April 20]; Available from: https://www.fda.gov/media/131911/download.
4. FDA. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. 2019 [cited 2020 April 20]; Available from: https://www.fda.gov/media/114034/download.
5. Code of Federal Regulations. Sec. 314.110 Complete response letter to the applicant. Applications for FDA approval to market a new drug 2019 [cited 2020 April 19]; Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.110.