The FDA needs to receive $1.2 billion between 2018 and 2022 to make possible the changes presented in the user fee reauthorization bill currently before Congress. Source: Drug Industry Daily

Amid a firestorm of controversy surrounding Mylan’s EpiPen, the FDA has approved an alternative. Source: Drug Industry Daily

The FDA is seeking feedback on its 2014 compounder registration guidance in the wake of calls for clarification of the differences between traditional and outsourcing compounders. Source: Drug Industry Daily

The FDA is proposing to shorten ANDA review timelines for certain generics sponsors that submit advance information to the agency. Source: Drug Industry Daily

Drugmakers now have the option of filing the FDA’s Field Alert Report (FAR) form online, following a successful four-year pilot program. Source: Drug Industry Daily