by Charlie Perrecone | Jul 2, 2013
Christopher Kelly reports on FDA.gov that The U.S. Food and Drug Administration (FDA), in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous,...
by Charlie Perrecone | Jun 28, 2013
Eric Palmer of FiercePharma.com reports that in just one week the European Committee for Medical Products for Human Use (CHMP) has recommended ten new drugs for approval. In the mix of the ten drugs included three medicines to treat cancer from Dendreon, Bayer, and...
by Charlie Perrecone | Jun 26, 2013
Pearl Pathways’ open house last Thursday the 20th welcomed in the new office with a bang. The afternoon get together was a fun way for visitors to stop by and see the new place. A refurnished interior to an old Indianapolis building on the south side of the city...
by Charlie Perrecone | Jun 25, 2013
FierceMedicalDevices’ Damian Garde shares that the amount of medical device inspections under President Obama’s terms has skyrocketed up 47%, hitting eight year highs. The number of warning letters handed out by the FDA is correlated with this growing number as well....
by Charlie Perrecone | Jun 25, 2013
Zachary Brennan of Outsourcing-pharma.com reports that the US FDA is recommending the usage of written quality agreements by pharma companies and CMOs. Although the FDA does not require such documents under cGMP (current good manufacturing practices) regulations;...
