Reading the news it seems like there are weeks to months between a company finishing their clinical trial and the FDA making a decision about approval of a drug. What does the FDA do during that time? How do they make the decision to approve a drug?
In: Biology
In addition to what retinue-webelo said, they tend to visit the manufacturer’s production facility as well as their clinical research department. They do a thorough review of everything, and there’s a lot. For each trial site you’re looking at stacks of paperwork that has to be checked. They look at training records for everyone involved, including sub contractors. Review SOPs. See how well the SOPs are followed. Go to some of the clinical sites, the doctors’ offices, and look at the original patient data. It’s a lot of work and for each visit they are generating their assessments and reports, which help inform the final decision.
Latest Answers