In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Site-Stability Guidance Arranges Drugs Into Three Risk Groups - Revised Draft

Executive Summary

Drugs could be classified into three risk categories for the purposes of site-stability data submissions based on potential adverse effects of drug substance and product stability due to site-transfer, FDA suggests in revisions to a draft guidance.

You may also be interested in...



Certificates Of Analysis Suggested As Alternative To Site-Specific Stability

Certificates of analysis from three commercial-scale validation batches could provide assurance that technology transfer has been successfully completed from a pilot manufacturing site to a commercial site, the Pharmaceutical Science Advisory Committee Site Specific Subcommittee determined Sept. 22.

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
UsernamePublicRestriction

Register

PS033991

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