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Pending industry user fee reauthorization will strongly shape the FDA's likely effort to use regulatory action to preempt legislative fixes for a number of issues in the next Congress, sources say.
Public comments obtained from the FDA's Division of Dockets Management show that while many organizations are generally supportive of the agency's draft guidance on conducting emergency clinical research without informed consent from participants, more work needs to be done.
Conservative and moderate House Democrats, known as "Blue Dog" Democrats, represent a pivotal voting bloc that will help decide what healthcare legislation makes it through the House and whether the White House and Democratic leadership can reach compromises, former lawmakers and Hill staffers say.
Novartis is taking advantage of China's inexpensive labor and rapidly growing drug market by building a $100 million research and development center in Shanghai, the company announced.
Adolor and GlaxoSmithKline's (GSK) Entereg faces yet another obstacle, as the FDA has issued an approvable letter requiring more data for the gastrointestinal drug.
In its first major announcement since the midterm elections gave control of the next Congress to the Democrats, the FDA outlined what it believes should be the priorities to improve drug safety without sacrificing innovation.
Neurocrine Biosciences saw the price of its stock fall 30 percent after announcing more delays for its insomnia drug indiplon and a loss of $39.1 million for the third quarter of 2006.
A class action claim alleging widespread Medicare fraud by the pharmaceutical industry was scheduled to go to trial Nov. 6 after a federal district court denied an industry motion to dismiss the suit.