The Food and Drug Administration (FDA) has calculated the regulatory review period for the human biological product ROCTAVIAN. This action is in relation to a request for patent term extension submitted to the U.S. Patent and Trademark Office by BioMarin Pharmaceutical, Inc. The total review period is 2,101 days, divided into 816 days for testing and 1,285 days for approval. The FDA encourages anyone who believes the dates are incorrect to submit comments or petitions by specified deadlines for consideration.
Simple Explanation
The FDA looked at how long it took to check if a medicine called ROCTAVIAN is safe to use and found it took 2,101 days. They are letting people who think the timeline is wrong say so, but the rules for saying this are a bit complicated.