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
UsernamePublicRestriction

FDA’s Woodcock Cautions Against Trying To “Legislate A New Generation Of Biomarkers”

This article was originally published in RPM Report

Executive Summary

New approaches to biomarker qualification are big part of industry’s agenda for “21st Century Cures,” but CDER Director Janet Woodcock remains concerned about efforts to legislate ahead of the science.

You may also be interested in...



Rx Vial Size: FDA Stresses Safety Issues Amid Push To Find Savings For Payors

There may be significant savings from eliminating wasteful packaging for high cost specialty drugs. The US FDA, however, is urging policy makers not to overlook the importance of patient safety in packaging issues.

New Tech Payment For Old Antibiotics: US Medicare Effort Brings Lots Of Interest

CMS streamlined process for enhanced payments is having an impact: seven antibiotic applications for New Technology Add-On Payment status in 2021—including one for a product that has been marketed for more than five years.

Mandatory Efficacy Trials: US FDA Affirms Broad Scope Of New Post-Market Authority

Updated guidance on its authority to mandate postmarketing studies affirms that a new power to impose requirements to look for diminished efficacy reaches beyond the opioid drug class.

Topics

UsernamePublicRestriction

Register

LL016789

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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