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

Sponsors Staying On Schedule With Postmarketing Requirements And Commitments

Executive Summary

About 80% of drug sponsors were on track with post approval studies in FY 2017, US Food and Drug Administration notes in its annual report on performance of applicants.

You may also be interested in...



US FDA's Postmarket Study Requirements: Industry Wants Standardization, Expert Input

PhRMA, BIO and Pfizer call for predictable process for setting postmarket commitments and requirements, periodic reevaluation of their necessity and feasibility, and FDA acceptance of novel trial designs.

Drug Sponsors Are On Schedule With Most Post-Approval Studies

US FDA's Gottlieb touts use of real world evidence as report shows vast majority of postmarketing requirements and commitments progressing on schedule.

Neuroblastoma Drug Development: Potential Surrogate Endpoint Gets US FDA Panel Backing

Advisory committee supports further research on end-of-induction response as an early interim clinical endpoint for drugs in treatment of high-risk neuroblastoma. FDA has approved two drugs for this rare disease in children, who have a 40-50% chance of long-term survival.

Topics

UsernamePublicRestriction

Register

PS142686

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