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" For FDA Reform Are Too Big For PDUFA

You may also be interested in...



FDA Pushes Back Against “Living” Benefit-Risk Assessment Management Plan

The Institute of Medicine urges the agency to create a publicly available document setting forth benefits and risks of drugs, with periodic updates, but FDA says it has no extra resources to handle such an effort.

User Fee Package Offers FDA Reforms From A House Wary Of FDA Power

House drafters’ dissatisfaction with FDA’s performance is evident in several provisions of draft user fee legislation. The agency would be required to finalize some guidances within a year of issuing a draft, which likely would provide more predictability for industry.

TREAT Act Wants Accelerated Approval Change, But Uses Existing Language

Anticipated legislation from Sen. Kay Hagan would copy federal regulations outlining accelerated approval to Food, Drug and Cosmetic Act, also encourage use of more broadly effective processes for expedited reviews.

Related Content

Topics

UsernamePublicRestriction

Register

OM006922

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