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 Guidance Policy Could Be Hurt By Ruling On Animal Drug Compounding

Executive Summary

A recent court ruling on the compounding of animal drugs has grabbed the attention of pharma lawyers, who say it could have ramifications for other FDA policies and provide ammunition for those challenging the agency’s use of guidance documents.

You may also be interested in...



Contamination, Mix-Ups Drive Up Drug Recall Totals for 2012

Injectables eclipsed oral solids as 2012 generated the fourth-most recalls ever. Contamination played a major role, particularly in generating several massive recalls at compounding pharmacies, while there were also contraceptive packaging snafus, problems in confronting tablet mix-ups and other issues that generated drug recalls last year.

FDA’s Compounding Oversight: What Price Safety?

As meningitis outbreak widens, FDA and members of Congress are calling for clarification of what jurisdiction the agency has over pharmacies, but agency officials are stopping short of asking for clear new authorities.

FDA’s Guidance Document To-Do List Grows

Since releasing its annual guidance agenda in December, FDA has added a number of guidances to its development agenda.

Related Content

Topics

Latest News
UsernamePublicRestriction

Register

PS053797

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