Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Regressing to the Mean: FDA Innovative Drug Approvals Drop Back to “Normal” Levels

This article was originally published in RPM Report

Executive Summary

Last year’s 39 NME approvals is not the “new normal,” Office of New Drugs Director John Jenkins declares. FDA approved just 27 NMEs in 2013. The return to normal also included a quiet December.

You may also be interested in...



“Grades” for FDA Approvals: When Academics Weigh in on Regulation

Physicians and patients need a better understanding of the quality of clinical trial design and data used to approve drugs, say researchers in a study published in JAMA. That led them to suggest a grading system to add another layer of information to FDA approvals, adding another academic suggestion for elaborating, explaining and embellishing FDA action.

FDA “Program” Reviews Are Positive So Far, But Are They Sustainable?

Early feedback on FDA’s review “Program” for new drugs and biologics is cautiously optimistic. FDA is meeting user fee goals. Communication between reviewers and drug sponsors has dramatically improved. And even trickier applications have done unusually well at advisory committee meetings. But FDA’s John Jenkins acknowledges that a lack of resources is straining the system – and forcing the agency to adapt.

Cancer Therapies: The Breakthrough Era

FDA Office of Hematology & Oncology Products Director Richard Pazdur, MD, sat down to discuss the state of cancer R&D, Breakthrough therapies, and how his staff pushes to complete those speedy three-month reviews during The RPM Report’s FDA/CMS Summit for Biopharmaceutical Executives in December. Here is a transcript of the conversation, edited for clarity.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS079672

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