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

FDA Compounder Inspections: States Taking Early Leave

Executive Summary

State inspectors did not accompany FDA for the full duration of facility inspections and now the agency is turning over the findings to them.

You may also be interested in...



FDA Compounding Definition Brings States Into Oversight Fold

State regulators seem to agree with FDA about confusion over regulatory responsibility, saying writing consistent definitions for compounding and manufacturing will help determine future FDA involvement.

Reimbursement Questions Add To Compounding Regulation Debate

Public Citizen asks whether CMS policy could have helped prevent the drug contamination at New England Compounding Center as Senate committee wants more information on states’ regulatory practices.

CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings

FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS056021

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