iwewlkws The Breakthrough Therapy designation is perhaps one the strongest incentives available to developers of innovative therapies in the US. Since implementation of the Breakthrough designation in 2012, FDA has designated about 110 products and approved 30 new products in this category. Now European Medicines Agency (EMA) has created its own version similar to the US regulatory pathway, called … Read more
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
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
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 … Read more
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
Almost every week FDA make public announcements about dietary supplements with risky ingredients such as unapproved drugs, hidden drug ingredients, dangerous chemicals and other ingredients. FDA’s web-site lists more than 700 such dietary supplements that are sold in the US market. The list is published based on tests conducted at FDA’s labs. However, very few retailers and distributors of … Read more
Last week we discussed the similarities and differences between pharmaceutical GMP sites located in China and India with regards to compliance with FDA requirements. This week the Regulatory Affairs Professionals Society (RAPS) published a much more detailed comparison from a different perspective, the review of a few FDA 483s issued to Chinese companies in 2015. Overall country-wide quality of … Read more
This Monday Chipotle closed all its stores for 4 hours during peak lunch time to hold a “Virtual” town hall meeting with its employees to “discuss” steps it has taken to improve food safety. Repeated incidences of microbial contamination of food sold at Chipotle outlets lead to more than 500 cases of food borne illnesses last year, leading to … Read more
In the year 2015, FDA approved the largest number of new drugs and biologics ever; 45 new drugs and biologics were approved. One third or 36% of these new products were first in class drugs meaning that they had novel mechanisms of action and were chemically and biologically different from any drugs approved in the … Read more
India and China have similar number of FDA-registered GMP manufacturing sites, 662 and 694, respectively. India and China manufacture similar kind of regulated products, primarily API and finished drug products, and very few biologics and medical devices. The two countries are culturally and economically quite similar as well. However, manufacturing sites in China have received … Read more
