Day: March 23, 2017

A recent study by the Tuffs Center for the Study of Drug Development indicates that on an average the 505(b)(2) NDAs take about 5 months longer to get approval from the FDA compared to the new molecular entities (NMEs). However, this is an incomplete story. The authors of the survey specifically looked at the time … Read more

Manufacturers of cell therapy products deal with several practical, logistical and scientific limitations much different from other biologic and drug products. Taking that into consideration, last year European Commission’s Directorate-General for Health and Food Safety (DGFHS), the governing body for the European Medicines Agency (EMA), released a draft guidance aiming to create special standalone rules … Read more