Newsletter - April 13, 2017
FDA’s Paradigm Shifting Approval of the First “Non-Diagnostic” Test
Last week, FDA cleared for marketing the first direct to consumer genetic test by 23 and Me and by that changed the way most genetic tests could be approved in future. Genetic tests have been controversial and challenging mainly because the conclusions drawn from genetic markers are seldom definitive. Read More
Who is Faster in Approving FDA or EMA and Why Should it Matter
An analysis published in the New England Journal of Medicine last week, it was proven with data that overall FDA is much faster than its nearest peer, the European Medicines Agency (EMA) in approving new products. Over the last 5 years, FDA took almost half as long as EMA to approve anti-cancer products, and about two-thirds of the time to approve anti-infectious agents compared to EMA. Read More
FDA’s Paradigm Shifting Approval of the First “Non-Diagnostic” Test
Last week, FDA cleared for marketing the first direct to consumer genetic test by 23 and Me and by that changed the way most genetic tests could be approved in future. Genetic tests have been controversial and challenging mainly because the conclusions drawn from genetic markers are seldom definitive. Read More
Who is Faster in Approving FDA or EMA and Why Should it Matter
An analysis published in the New England Journal of Medicine last week, it was proven with data that overall FDA is much faster than its nearest peer, the European Medicines Agency (EMA) in approving new products. Over the last 5 years, FDA took almost half as long as EMA to approve anti-cancer products, and about two-thirds of the time to approve anti-infectious agents compared to EMA. Read More
