The Food and Drug Administration (FDA) has determined the regulatory review period for a human biologic product named OMISIRGE, which is used for treating certain blood cancers. The review period, which is 4,563 days long, involves a testing phase and an approval phase and influences the potential extension of the product's patent. The FDA's decision follows an application by Gamida Cell Ltd. for patent extension, and the public can provide comments or request further determinations by specified deadlines.
Simple Explanation
The FDA looked at how long it took to check and approve a special medicine called OMISIRGE that helps fight some blood cancers. They found that this took a long time, and now they're thinking about giving the makers a little more time for their special recipe (patent) to stay theirs and not be copied by others.