Daily Archives: April 4, 2007

DDMAC Enforcement Down – PDUFA Dollars Up – What is Wrong with that Formula?

As we are in the midst of approval for PDUFA IV, there has been a lot of talk from the FDA about the need for increased funds to bring greater focus on drug safety and even monitoring of marketing activities. … Continue reading

Posted in FDA Image, PDUFA, Warning Letters | 1 Comment