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

House Compounding Bill Would Regulate “Outsourcing Facilities” With Volume Limits

This article was originally published in The Pink Sheet Daily

Executive Summary

Reps. Griffith, DeGette, and Green co-sponsor bill to improve FDA oversight of compounding with some provisions similar to Senate bill, possibly opening door to compromise.

You may also be interested in...



Track-and-Trace Bill Clears House With New Electronic Labeling Language

Safeguarding America’s Pharmaceuticals Act passes on suspension calendar, but likely sets up fight with Senate in conference.

US FDA’s Califf: We Don’t Need Much Help From Congress On Rare Diseases

The FDA commissioner also does not want the agency setting goals for rare disease treatment development.

Accelerated Approval Now Starting Point For Gene Therapy Development, US FDA’s Marks Says

Expedited approval pathway had been a secondary option when traditional approval was not possible, but the CBER director wants surrogate endpoints increasingly considered from the beginning, especially with pediatric rare disease gene therapies.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS076242

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