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

BIO's "Big Ideas" Include Expanding FDA's Mission, Allowing "Progressive Approval"

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA would no longer just be tasked with protecting public health but also with encouraging product development under ambitious legislative proposals that BIO is set to reveal.

You may also be interested in...



“Breakthrough Therapy”: New Pathway in FDASIA May Point The Way To Future Reforms

A new FDA designation process for “breakthrough” drugs is one of the few “innovation” features of the FDA Safety & Innovation Act. It is likely to be very attractive to biotech sponsors, though its impact on actual product approvals is uncertain at best. The real “breakthrough,” though, may be in the collaborative model that led to the legislation – and that is an important message for sponsors hoping for bigger reforms ahead.

Senior CDER Management Panel Could Facilitate Novel Therapy Approval

CDER Director Janet Woodcock is creating an executive-level forum to deliberate medical policies, including those needed to smooth drug reviews. She envisions stakeholder input on topics for discussion by the panel.

Senior CDER Management Panel Could Facilitate Novel Therapy Approval

CDER Director Janet Woodcock is creating an executive-level forum to deliberate medical policies, including those needed to smooth drug reviews. She envisions stakeholder input on topics for discussion by the panel.

Related Content

Topics

UsernamePublicRestriction

Register

PS072433

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