Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Compounder Definition In House Bill May Use Blended Metrics

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA and stakeholders reiterate that volume cannot be the sole measure of whether a compounder should be regulated like a drug manufacturer; Rep. Griffith pitches potentially using it and other indicators to draw the line.

You may also be interested in...



Compounding Bill In Senate Gets Bipartisan Push For Floor Vote

HELP Committee leaders Harkin and Alexander write letter arguing that FDA’s warnings of more problems from tainted compounded medications have come true and that their legislation should gain a vote next month.

Pink Sheet Podcast: Monkeypox Vaccine EUA, Drug Pricing Bill Fallout, US FDA’s IT Upgrade

Pink Sheet reporters and editor discuss the new monkeypox vaccine EUA, the potential impact of drug pricing legislation, and how things may have been different if the FDA already had a desired technology upgrade.

Patient-Focused Drug Development Events May Be Giving Way To Small, Private Meetings With FDA

Patient listening sessions, which are easier to schedule, have overtaken traditional patient-focused drug development meetings in terms of volume, although US FDA’s data may be incomplete.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS075972

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