Evolving FDA (DrugWonks.com)
At a recent FDA conference on the Critical Path Initiative, FDA Commissioner Andrew von Eschenbach described 21st century medicine as needing to be "personalized, predictive, and participatory," notes blogger Peter Pitts. In his entry, Pitts discusses the challenges faced by the FDA in the process of "evolution" touted by von Eschenbach.
the FDA's View of Supply-Chain Issues? (Drug Channels)
Last week, the FDA released a report on drug counterfeiting, one of the main points of which was the agency's decision lift its stay on the PDMA. In his entry, blogger Adam Fein praises this move, but criticizes the FDA's failure to discuss how much free market innovation has already improved the safety of the drug-distribution channel.
Black Box Warnings
and the CMS (Eye On FDA)
"When the FDA slaps a Black Box warning onto a drug, Medicare Part D formularies may be allowed pull the drug from coverage," writes blogger Mark Senak. In his entry, Senak discusses Black Box warnings and the potentially negative involvement of Medicare in the process.