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Republicans on the Senate HELP Committee say they are concerned that FDA is using draft guidance documents to set substantive policy, which they argue puts companies in a difficult position.

You may also be interested in...



Biosimilar Approval Is New Focus In Senate Critique Of FDA Guidance Policy

Commissioner Hamburg describes a Catch-22, warning that pressure to finalize guidances faster without more resources could result in fewer discretionary guidances, disappointing stakeholders.

Pfizer Says FDA Draft Guidance Is Just Fine; Congress Should Be Patient

In an unusual move, industry rep indicates comfort with draft guidance implementing biosimilar pathway.

Accelerated Approval Labeling Caveat Draws Industry Ire

FDA draft proposal could lead providers, patients and insurers to mistakenly believe a drug cleared under the expedited pathway does not meet the same standards as other drugs, PhRMA and BIO say.

Related Content

Topics

UsernamePublicRestriction

Register

PS056111

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