The Food and Drug Administration (FDA) announced the determination of the regulatory review period for the drug SOHONOS, which is used to treat fibrodysplasia ossificans progressiva in certain children and adults. This determination is related to a patent extension application made to the U.S. Patent and Trademark Office (USPTO). FDA found that the drug underwent a lengthy review process, including 6,657 days of testing and 869 days of approval proceedings. People who believe any of the review dates are incorrect can submit comments to FDA, and petitioners can also request a review of the applicant's diligence during this period.
Simple Explanation
The FDA looked at how long it took to check if a special medicine for a rare bone problem was safe and worked well, and they found that it took a very long time. Now, people can say if they think any of the times were counted wrong.