Use FDA’s Processes to Speed US Patient Access to Cuban Lung Cancer Vaccine

Medical researchers in Cuba invented a vaccine, called CimaVax-EGF, for lung cancer. CimaVax has been tested in about 7 well-designed clinical trials in patients with advanced non-small-cell lung cancer (NSCLC), and used to treat about 5000 patients over the last 2 decades. This one of a kind vaccine costs about $1 per shot and patients need to take one shot every month. … Read more

Priority Review Vouchers and FDA: Agency Complains of Increased Work

A recent GAO report on the public support for the Priority Review Voucher (PRV) program presents a mixed picture where the industry loves the program and wants it to be maintained while the FDA has an exactly opposite opinion. PRVs have been around for about 7 years since the first PRV program was implemented in 2007 with great fanfare. … Read more