Newsletter - February 25, 2016
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. Compare that to the 11 drugs approved by FDA for treatment of NSCLC which costs thousands of dollars per month and carry extensive side effects. Read More..
GAO Questions FDA’s Post-Marketing Oversight for Drugs Approved via Expedited Programs
A survey conducted by the Government Accountability Office (GAO) found that FDA does not have robust processes to oversee the safety of drugs approved under expedited programs. There are 4 programs under which new drugs can be approved by FDA under reduce testing burden and shorter review times. These programs are priority review, breakthrough therapy designation, accelerated approval, and fast track program. Read More..
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. Compare that to the 11 drugs approved by FDA for treatment of NSCLC which costs thousands of dollars per month and carry extensive side effects. Read More..
GAO Questions FDA’s Post-Marketing Oversight for Drugs Approved via Expedited Programs
A survey conducted by the Government Accountability Office (GAO) found that FDA does not have robust processes to oversee the safety of drugs approved under expedited programs. There are 4 programs under which new drugs can be approved by FDA under reduce testing burden and shorter review times. These programs are priority review, breakthrough therapy designation, accelerated approval, and fast track program. Read More..
