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 “Intercenter Institutes” Legislation Headed For Senate Mark-Up

This article was originally published in RPM Report

Executive Summary

FDA would be directed to test the concept of joint drug/device/diagnostic reviews in at least one therapeutic area under legislation proposed in the Senate. The idea of further integrating medical product reviews is already part of the Vice President’s cancer “moonshot.”

You may also be interested in...



Don't Rush To Reorganize FDA, McClellan Says

Former commissioner says agency has to think about getting biggest bang for the buck when considering a reorganization to disease-focused teams.

The Next Step In FDA Reform? Consolidated Drug/Device Groups Proposed By FOCR

A Friends of Cancer Research proposal to create FDA drug-device review teams in oncology, cardiology and neurodegenerative disease could find a home in the next round of FDA reform legislation. PDUFA VI. Current and former agency officials are cautiously optimistic about the idea, but combining review operations with different statutory underpinnings will be challenging.

Amgen’s Imlygic Approval A Milestone For Oncolytic Cancer Vaccines

Company prices Imlygic (T-VEC) cancer vaccine at the average cost of $65,000, aims to launch within a week.

Topics

Related Companies

UsernamePublicRestriction

Register

PS079907

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