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

Drug Sponsors Mostly 'On Track' With Postmarket Study Requirements

Executive Summary

US FDA's annual report on the status of postmarketing requirements and commitments shows 84% of open postmarket requirements for NDAs and 91% for BLAs were progressing on schedule as of Sept. 30, 2016; about half have not yet begun.

You may also be interested in...



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.

Patient Data In Drug Reviews Would Be Encouraged In Proposed Amendment To User Fee Bill

Rep. Matsui withdrew amendment on FDA’s use of patient experience data during health subcommittee markup of user fee reauthorization legislation, but it may be considered in full committee markup following agency input. Chair Eshoo says the provision specifying contrast agents must be regulated as drugs needs to be reworked to include ophthalmic products.

Topics

UsernamePublicRestriction

Register

PS122101

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