HBW Insight is part of the Business Intelligence Division 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


FDA’s Regulatory Rock And Hard Place: How To Handle Draft Guidances

Executive Summary

Republicans on the Senate HELP Committee say they are concerned that FDA is using draft guidance documents to set substantive policy, which they argue puts companies in a difficult position.


Related Content

Biosimilar Approval Is New Focus In Senate Critique Of FDA Guidance Policy
Pfizer Says FDA Draft Guidance Is Just Fine; Congress Should Be Patient
Accelerated Approval Labeling Caveat Draws Industry Ire
FDA Opioid Policy: Senate Takes A Speak Softly Approach
FDA Opioid Policy: Senate Takes A Speak Softly Approach
FDA’s Funding Bridle: House Demands Opioid Guidance, Limits Compounding Boost
FDA’s Top Agenda Maker: Commissioner, Congress – Or The Courts?
Congress Dives Into Biomedical Innovation: Will It Drown In A Deep Sea Of Competing Needs?
Journal Reprint Guidance: Industry And FDA Still At Odds Over Off-Label Information
Industry Involvement In Guidance Development Encouraged By FDA Working Group





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