Newsletter - March 23, 2017
Special GMP for Cell Therapy Products: European Draft Guidance Gets Mixed Reviews
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. Read More
Time to Approval of 505(b)(2) NDAs is Shorter Than Conventional NDAs
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. Read More
Special GMP for Cell Therapy Products: European Draft Guidance Gets Mixed Reviews
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. Read More
Time to Approval of 505(b)(2) NDAs is Shorter Than Conventional NDAs
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. Read More
