WASHINGTON – Dealing with pain has been a routine part of life for millions of Americans. Now, it's being bumped up to a national priority with a focus on treating it as a complex disease in itself.
WASHINGTON – If the FDA gets its way, it will see a 17 percent increase in its 2013 budget, but nearly all of that will be footed by the biopharma and food industry through new and increased user fees.
WASHINGTON – While the package of draft guidances the FDA released last week on biosimilars held no surprises, it also was light on the specifics needed to produce predictability in the new pathway.
"Show me the benefit" was the mantra Wednesday when an FDA advisory committee critiqued the ability of Amgen Inc.'s Xgeva to prolong the time until bone metastasis in men with castration-resistant prostate cancer.
While the reauthorization of PDUFA was the focal point of a House subcommittee hearing Wednesday, lawmakers also began consideration of two acts that require and incentivize pediatric drug trials.
In the opening congressional hearing to reauthorize PDUFA, the discussion Wednesday ranged from the dangers of the Brazilian Blowout hair straightener to the Tobacco Control Act.
