Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

On Tap: Novel Agents Awaiting US FDA Action In 2017

Executive Summary

New molecular entities and novel biologics on US FDA's user fee calendar for 2017.

An interactive chart of the more than 40 novel agents in line for FDA approval decisions in the upcoming year.

Click the column headers to sort the chart by parameters including sponsor, Prescription Drug User Fee Act (PDUFA) goal date, therapeutic area, and submission date. The search box can be used to filter the data. To see only approved products, for example, type "approved" in the box; to see only unapproved agents, type "pending" in the box.

This chart is adapted from the FDA Performance Tracker's User Fee Goal Dates chart, which is updated weekly and includes supplemental and non-NME original submissions as well as novel agents.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS120068

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel