Here is another good news/bad news column about the 112th Congress.

Today, URL Pharma was acquired by Takeda for nearly $800M.  The story here in brief is that for hundreds of years, colchicine was used for the treatment of gout and other conditions; it was an effective drug but had to be used carefully. URL invested in the formulation development and clinical studies required for colchicine, and ultimately received FDA approval in 2009. 

When an imperious bully like Fidel Castro starts to fear, his instinct is to try to sow fear among his enemies. Today, with his student and benefactor, Venezuelan leader Hugo Chávez, dying of cancer, what the Cuban dictator fears most is that his bankrupt regime in Havana is about to lose billions in critical aid and oil.

Adding a new mandatory "comparative effectiveness" test to the approval process for new drugs in the reauthorization of the Food and Drug Administration (FDA) Prescription Drug User Fee Act constitutes a needless waste of time and money.

The Food and Drug Administration's mission has become increasingly complex. As the sophistication of its mission increases, so must the tools it uses for accomplishing its work.

The FDA is charged with assuring the safety and efficacy of new drugs while also making them available to the public as quickly as possible. To help meet these competing pressures, Congress enacted the Prescription Drug User Fee Act (PDUFA) in 1992. This Act imposed performance goals on the...

Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992. The authors model and quantify the impact of PDUFA-I and -II on drug approval times.