21 December 2017 - The number of new molecular entities approved by the US FDA in 2017 (46 so far, though that number does not include the high-profile CAR-T and gene therapies approved this year) has now topped the all-time high of new molecular entities approved in any year except 1996.

But the record number of approvals comes as experts, including CDER Director Janet Woodcock, have expressed reservations about tracking new molecular entities (NMEs) approvals like a horse race, or comparing one year's approvals to another since the agency is limited by the applications it receives.

Frank David, MD, PhD, managing director of the consulting firm Pharmagellan, explained to Focus: "Over 90% of drugs that are submitted to FDA get approved, so the NME count mainly a reflection of the number of applications - which, in turn, reflects the registration trials that were funded 2-3 years ago. With such relatively small numbers, there will always be noise - two more NMEs this year, three fewer next year, and an occasional year with many more or many fewer - but I don't think the short-term comparisons mean much."

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