A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Depomed is taking the FDA to court, claiming the agency violated federal laws and its own regulations when it denied the company’s orphan drug Gralise seven years of marketing exclusivity. The FDA unfairly required “additional hurdles” for Gralise’s (gabapentin) orphan exclusivity — barriers that are not in the Orphan Drug Act or FDA regulations, Depomed alleges in its complaint, filed Tuesday in the U.S. District Court for the District of Columbia. Drug Industry Daily