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

Case Studies In FDA's Regulatory Interpretation Of Clinical Trials

Executive Summary

For more than 15 years, the Pink Sheet's Drug Review Profile series has looked closely at FDA approval documents, providing a long view of the pitfalls and pitches presented in the NEJM series on interpreting clinical trial results.

You may also be interested in...



A Cautious Guide To The Interpretation Of Clinical Trials From NEJM

Determining the success or failure of a randomized trial requires looking beyond the p-value for the primary endpoint, review articles in The New England Journal of Medicine urge.

Patient Voices Swayed FDA's Imlygic Review Team

Testimony from patients about the cosmetic and psychological advantages of seeing melanoma lesions shrink was a key element in agency's decision to offer full approval to Amgen's talimogene laherparepvec despite serious concerns about the clinical meaning of the pivotal trial's durable response rate endpoint.

FDA Used Regulatory Loophole To Save Novartis' Farydak

FDA shoehorned third-line multiple myeloma therapy into accelerated approval program using loophole in concept of unmet medical need; maneuver also gave agency ability to define a do-over of development plan.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS119132

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