by Raleigh Malik | Apr 25, 2013
FDA is calling for an international consortium of cardiovascular registries to coordinate data from multiple disease registries for use in testing the efficacy and safety of medical devices per a recent article on RAPS.org. Patient registries have been used in the...
by Raleigh Malik | Apr 24, 2013
The FY2014budget for FDA requests about $821M more than it received in FY2012 and part of the funding request is an additional $10M for inspections in China. Increasing foreign inspections of drug manufacturing sites will prevent unsafe drug products from entering the...
by Raleigh Malik | Apr 23, 2013
On April 9, 2013, Stephen J. Ubl, president and CEO of AvaMed praised Congress for supporting the repeal of the medical device tax. Ubl stated that device manufacturers are paying an estimated average of $194 million per month in medical device payments, and the tax...
by Raleigh Malik | Apr 10, 2013
The FDA plans to issue draft guidance proposing that manufacturers of automated external defibrillators get agency approval. These devices provide early defibrillation to patients suffering from cardiac arrest, a leading cause of death in the United States. The FDA is...
by Raleigh Malik | Apr 10, 2013
Although the FDA retains authority for drug approvals, advisory committees of non-agency experts review applications and safety studies, as well. However, finding members without conflicts of interest to serve on these committees is difficult for the FDA. Recently,...
