Pink Sheet

Drug Sponsors Who Fail To Submit One-Time Marketing Report Face Big Penalty

08 Feb 2018

US FDA could move sponsor's products from active to discontinued section of Orange Book if agency doesn't receive the FDARA-required report by Valentine's Day.

The referee gave a red card for the player in stadium — What’s going to happen if a sponsor doesn’t turn in its report by Feb. 14? Let’s just say they are not getting chocolates.

Like a middle school teacher repeatedly reminding students that a big paper is due, the US FDA continues to prompt drug sponsors to submit a mandatory one-time report on marketed products.

As part of the 2017 FDA Reauthorization Act, sponsors must submit a one-time update of the marketing status for all...