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
- 3 Little-Known Biotechs Working On Potential Blockbusters
- The Savvy Buyer's Guide to Winning Deals in a Seller's Market
- 8 Ways to Increase Your Credit Score to Get the Lowest Mortgage Rates
- Is This Warren Buffett's Next Cinderella Story?
- Tesla Motors, Inc. Stock Gets a Boost From a Key Win in Its Dealer Battle
- Biglari Holdings vs. Groveland Capital: Whose Alamo Is It?