This post is the fourth in a brief series about the FDA drug approval process. The series is designed to answer the question about why U.S. prescription drugs are so expensive by illuminating the FDA drug approval process, stage by stage.
In my last post in this series, I focused on the clinical stage, and the one before that was the preclinical stage. Today’s post highlights the new drug application (NDA) review stage, which is the final gate before getting a new drug on the market.
Pre-NDA Review Meeting
Prior to the submission of a New Drug Application (NDA), the FDA and sponsor meet to discuss and agree upon the content and formatting of the NDA. The sponsor should leave the meeting with a good understanding of their readiness for filing and their likelihood of approval.
The drug sponsor formally asks the FDA to approve a drug for marketing in the United States by submitting an NDA. An NDA includes all animal and human data, the analyses of that data, information about how the drug behaves in the body, and a description of how it is manufactured.
After an NDA is received, the FDA has 60 days to decide whether the application is complete enough to go through formal review. If it is not, the FDA asks the sponsor for more information, and sometimes even more studies. Once the FDA finds the application to be sufficient, an FDA review team is assigned to evaluate the research on the drug’s safety and effectiveness. The review timeline varies, depending on several factors: whether other, similar drugs are already in the market; whether the drug treats a condition that is lacking sufficient treatments; whether the drug is the first of its kind, scientifically; and so forth.
Note: Generic medications require an abbreviated NDA (ANDA) that does not include preclinical (animal) or clinical (human) testing. Rather, generic medications must scientifically demonstrate that the product is a bioequivalent to the innovator drug.
The FDA reviews the proposed post-market labeling for the drug and ensures that it communicates appropriate information to both healthcare professionals and consumers/patients.
The FDA inspects the facilities where the drug will be manufactured to determine a facilities’ compliance with regulations and the Food, Drug and Cosmetic Act.
The FDA approves the NDA, denies the NDA (very rare) or issues a complete response letter (CRL) that provides detailed information about why the application cannot be approved in its current form, as well as instructions regarding the additional steps the sponsor needs to take to achieve approval. Sponsors that receive CRLs have up to 12 months to address the deficiencies cited in the CRL.
Once a new drug has (finally!) been approved for use by the FDA, its owner releases it to the market, which includes educating patients and physicians about the drug’s benefits, risks, and appropriate use. The drug then enters its final stage, post-marketing, where it lives until it is retired from use.
Stay tuned for the final post in this series on the post-marketing stage. Until then, feel free to download our latest guide by filling out the form below.