Biotechnology/Biologics US-FDA

The U.S. Food and Drug Administration today announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

...including adalimumab (Humira, Abbott), etanercept (Enbrel, Amgen/Wyeth), infliximab (Remicade, Centocor), and certolizumab pegol (Cimzia, UCB Inc.)—for data on all cases of cancer reported in children and young adults...

...investigating whether four drugs used to treat rheumatoid arthritis and other immune system diseases might increase the risk of cancer in children.

The new system, called the Sentinel Initiative, will allow officials from the Food and Drug Administration for the first time to monitor almost immediately how drugs affect health...

FDA is holding a meeting, launching a pilot, and releasing a concept paper about drug names next month.

In the midst of yet another controversy about whether vaccines cause autism, the federal government will hold its first ever public meeting on Friday to discuss a governmentwide research agenda to explore the safety of vaccines

Meds OK'd right on deadline are 4 times more likely to have major problems

Scientists have the first evidence that those "reprogrammed stem cells" that made headlines last month really have the potential to treat disease: They used skin from the tails of sick mice to cure the rodents of sickle cell anemia.

Effort Part of Agency&8217;s Response to Institute of Medicine Recommendations

The government is mulling more "behind-the-counter" sales, to let patients buy certain medicines directly from pharmacists without a doctor's prescription.