Improving Efficiency
OGD's increasing workload complicates its ability to do reviews in a reasonable timeframe. There is the need for a science-based approach and risk assessment as part of the review process. A science-based approach and risk assessment by firms help and speed up the review process.
OGD is working to process applications more efficiently and save time without affecting the safety or efficacy of the application. OGD's most important job is to ensure that unsafe or non-efficacious applications are not approved.
Often, OGD will receive several applications of the same drug product, at the same time or at the same time of the day. Under OGD's cluster review process, OGD will process all these applications using a single team. Sometimes, a single reviewer will look at all of the applications. In this case, applications will be reviewed according to a queue.
Sometimes, a team of reviewers will get all these applications and review them together.
