Drug approvals

An IND includes information from animal studies, toxicity, manufacturing, clinical protocols (study plans), prior human research (if any) and finally information about the investigator. The FDA has 30 days to review the IND submission this protects volunteers in clinical trials from risk. After the IND review, the FDA can respond in one of two ways, with approval to begin clinical trials or with a clinical hold to delay/stop clinical trials.

Providing the drug developer has sufficient evidence from Step 1, Step 2 and Step 3 of the development, they can submit a New Drug Application (NDA) to the FDA. The aim of an NDA is to show that the drug is safe and effective for people to use. The FDA reviews the application to ensure it is complete. If the outcome of the review discovers the application is not complete, the FDA will refuse to file the NDA; however, if it discovers the NDA is complete the FDA has 6–10 months to decide whether or not to approve the drug. During the next 6-10 months each member of the review team conducts a full review of their section of the application and FDA inspectors travel to clinical study sites. The project manager assembles individual reviews and documents into an “action package.” The review team then issues a recommendation, and a senior FDA official makes a final decision. If a drug is approved by the FDA, they work with the drug developer to produce the prescribing information, known as “labeling”. Drug developers file a supplemental application (sNDA) if they want to make any significant changes from the original NDA, this can include changes in formulation, labeling, or dosage strength. This needs to be reviewed by the FDA and approved before the changes can be made.