FDA

Biosimilars, also known as follow-on biologics, may eventually expand access and provide patients a more affordable alternative to innovative, lifesaving medicines. However, there are a few important safeguards that must be put into place before these “similar but not the same” versions of biologics can be safely introduced to the public.  Join Dr.

Yes, you heard it right. The FDA is contemplating the use of social media. One attendee,Porter Novelli's Peter Pitts, dubbed it,"Super Bowl of Part 15 Hearings.”

The hearing got,

"under way yesterday in a near-capacity federal conference hall.

With obesity becoming a worldwide epidemic, there’s no need to question why new treatment options are important. In fact, according to recent reports, obesity-related health and economic costs are estimated at $100 billion per year.

Unfortunately, the options currently available to treat obesity only produce modest weight loss. But what about the conditions often associated with obesity, like diabetes, heart disease, osteoarthritis and sleep apnea?

There are more than 5 million patients suffering from gout. Unfortunately, most gout patients steer clear of medications unless experiencing a flare-up.

With the gout population getting older, fatter and more complex, and with no new treatments approved for the last 50 years, is there hope for gout sufferers?

Actually, there is. There are two new drugs awaiting FDA approval in 2009 that may offer long-term gout management and provide physicians with the ammo needed to improve patient education. While the drugs prove to be efficacious, questions regarding safety remain.

Today is a very special day for those of us that work in the field of animal biotechnology.  Today, the FDA announced the long-awaited draft guidance describing a regulatory framework for governing genetically engineered (GE) animals. In addition, USDA is seeking comment on their coordinated role in the regulatory process.

BIO President & CEO Jim Greenwood and the Chair of BIO's Board of Directors, Dr.