Medtech Insight 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

Shortcuts Pursued in Effort to Close Compendial Gaps

This article was originally published in The Gold Sheet

Executive Summary

Officials with FDA, the U.S. Pharmacopeia and the pharmaceutical industry are looking for a quicker way to remedy a situation underscored by the 2008 heparin crisis: the need to update hundreds, perhaps thousands of the compendial standards that the U.S. Pharmacopeia developed and FDA enforces.

You may also be interested in...



Five Years Later, Legacy Biologics Still Face ‘Next Heparin’ Risks

Several factors continue to slow efforts to modernize legacy biologics’ compendial monographs against fake ingredients like the ones someone put in heparin in 2008. Hyaluronate, the ‘poster child’ for monograph modernization; New NDAs for pancreatin create new modernization challenges; Heparin maker vertically integrates to prevent adulteration.

Fercy Warning Letter Confirms OTC Monograph Fears

Drug maker in China found to exploit gap in U.S. regulatory system, exporting OTC monograph drugs without key quality controls or registration until FDA inspection led to import suspension.

USP Told 'Big Four' Heavy Metals Should Take Priority in Compendial Revision

Go after 'big four' heavy metals first in revising outdated compendial standard, USP told. Start with arsenic, cadmium, lead and mercury, not all 31 listed metals, industry says in response to stimuli article, which would let them choose methods for meeting performance-based standards. Residual solvents chapter proposed as template. EMEA catalyst guideline lauded. Some want dosing frequency considered in setting toxicology limits.

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

PS000616

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