Acknowledging that the train may have already left the station for Glaxosmithkline plc's (GSK) Avandia, some advisory committee members and other experts looked down the track last week to give the FDA an earful on how to get more meaningful data about diabetes drugs and avoid the process that derailed the one-time blockbuster Avandia.

A replay of the data from the RECORD trial seemed to reassure many members of two FDA advisory committees about the use of GlaxoSmithKline plc's diabetes drug Avandia, but they admitted that it's probably too late to rehabilitate the drug's reputation.

The president is getting gruff with patent trolls, using his executive powers to waylay their frivolous lawsuits and urging Congress to pass legislation that would make trolling far less appetizing.

Some advisory committee members may think they're listening to a broken record when they convene for the third time in seven years Wednesday to once again discuss the cardiovascular (CV) risk of GlaxoSmithKline plc's (GSK) diabetes drug Avandia and its open-label, noninferiority RECORD trial.

Patients getting their four minutes to say how an experimental drug changed their life or gave them hope have become a routine part of nearly every FDA advisory committee meeting – as routine as the call to order or the conflict of interest statement. And as routine as the adcom moving on with little regard for what they’ve said. The public hearing speakers, along with the usually silent patient member of the panel, seem to have one function – to let the FDA check off the box for patient involvement. But patients with orphan diseases and their families deserve more...

"Mind the gap" was the warning call Thursday as the FDA's symposium on medical countermeasures (MCMs) turned to the need for pediatric countermeasures for radiation exposure.

Revamping Medicare Part D, for some people, would be the health care equivalent of remaking Gone with the Wind. Some classics just shouldn't be messed with, they reason.

When it comes to the compounding of drugs, the one thing everyone agrees on is that something needs to be done to ensure the safety of the products. But how to do that is another matter.

Despite an increase in transparency and collaboration in China, the safety of drugs and other products imported from the country remains a concern in the U.S.