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

Senator Manchin Goes to White Oak

This article was originally published in RPM Report

Executive Summary

The open public hearing portion of an advisory committee is often emotional and sometimes persuasive. It is not usually a forum for a give-and-take with a sitting US Senator. But it was during a two-day review of the DEA scheduling status of hydrocodone combos.

You may also be interested in...



Primatene HFA Turned Down By FDA Panel; Will Capitol Hill Accept Decision?

The Primatene Mist phase-out has been a topic of interest for one prominent Republican Congressman, Texas’ Michael Burgess. He’s been eager for FDA to approve a replacement, but Armstrong’s reformulation doesn’t look ready just yet. In an interview, Burgess says he won’t tell FDA what to do – but will keep a close eye just the same.

Zogenix Zohydro Launch Will Test FDA’s Balanced Approach On Opioid Pain Reviews

FDA approved Zogenix’ single-entity hydrocodone product following a negative advisory committee meeting, and is facing ongoing opposition as the drug’s launch begins. The agency argues the risk is consistent with other extended-release opioids – and abuse-deterrent technology is too new to require.

Sen. Burr Tries To Pull FDASIA Over For Speeding As Senate Sends Bill To White House

The North Carolina Republican spends more than two hours talking about the user fee bill and other issues in an apparent effort to delay a final vote, but the Senate easily passes it.

Topics

UsernamePublicRestriction

Register

PS081101

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