Once all the data is collected and analyzed, the company can submit a new drug application. It includes data from the trials, the preclinical information, and details about how the treatment is manufactured. If the FDA accepts that application, the agency has 10 months and, in some priority cases, six months to make a decision.
During that review period, the FDA may hold an advisory committee meeting, where an independent group vets the drugmaker's data. From there, the group votes on whether the drug is safe, effective, and if the benefits outweigh the side effects. The FDA takes the committee's view into consideration but is not bound to follow its advice.
Finally, the FDA gives its decision. It can approve the drug or issue something called a complete response letter.
This is where the FDA explains why the drug didn't get approval. The drugmaker then decides whether to correct the mistakes or collect any missing information before reapplying.