An approvable letter is sent by the FDA when a drugmaker's New Drug Application is not sufficient for approval, but has the potential to be approved at a later date. The letter spells out what problems the FDA had with the marketing application. Often times further meetings with the FDA are required to determine what needs to be done to get the drug approved.
Recent Mentions on Fool.com
- Thanks to Netflix, Comcast's Acquisition of Time Warner Cable May Be in Jeopardy
- $8.3 Billion Buyout: InterMune Inc. Stock Shareholders Can Breathe Easier Thanks to Roche
- How Warren Buffett?s Luck Changed
- How Biofuels and The Boeing Company Are Reshaping the Global Aviation Industry
- This Is Why Ninja Turtles Didn't Need to Be Great
- Is This Popular High-Yield Investment Headed for Extinction?