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

Earning The Right To Say FDA Registered Outsource Facility

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s welcoming inspections to newly registered 503B “outsourcing” compounding facilities are a harsh first hug for the segment: large recalls and adverse inspection reports continue to be the first notable results from the inspections.

You may also be interested in...



Autism Feedback To FDA: Focus On Communication, Redefine 'Irritability'

US FDA’s 22nd Patient-Focused Drug Development meeting focused on the challenging disease of autism. It also showed how far FDA has come in embracing the patient-input process over the past five years.

SMA Patient Meeting Showcases FDA Flexibility – And Appreciation From Advocates

US agency's top neurology review officials received warm reception during Patient Focused Drug Development meeting for Spinal Muscular Atrophy. They also delivered a strong message of continued engagement beyond the first drug approval.

FDA Patient Feedback Meetings: External Model Ramping Up In 2017

US agency has started transitioning to a new model for Patient-Focused Drug Development meetings, with agency officials attending four externally hosted meetings so far, with at least three more planned for the next few months. So far, the Neurology Products Division has been particularly active with the external meetings.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS077967

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