Pharma

This is the FDA’s year to shine, but can biopharma keep up as regulators continue to rev up chart-topping numbers?

The year isn’t quite over yet, but it’s clear that the FDA is giving itself high marks for productivity and overall performance for 2018. And they probably won’t get much pushback from the industry on that score, where the approval rating for agency commissioner Scott Gottlieb continues to run sky high after his first full year in that position.

A year-to-date FDA self-assessment from Khushboo Sharma, the acting chief of the Office of New Drugs, highlights the new record for drug approvals in 2018, with 55 NMEs green-lighted — with a chart-topping 42 priority reviews.

This is no fluke. Sharma provided a breakdown on the number of INDs filed with the agency — which continues to be the premier place where drug developers go to seek their first OK.


In order to read this article, you must be an Endpoints News subscriber. (It's free to subscribe.)

← Go back

We produce two daily email newsletters designed to give you a complete picture of what's important in biopharma. It's free to subscribe and never any spam. Join 51,100+ biopharma executives who read Endpoints News every day.

Access is subject to the terms in our Privacy Policy.


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 51,100+ biopharma pros who read Endpoints News by email every day.

Free Subscription

VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Director Process Development
Elektroki Boston, MA
Director Process Development
Elektroki Boston, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

Visit Endpoints Careers ->