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 BIOLOGICAL LOT RELEASE COULD BE HANDLED BY OUTSIDE GROUPS, BIO SAYS; PhRMA DEFINES "BROAD PRINCIPLES" OF FDA REFORM; HIMA WANTS OPTIONAL OUTSIDE REVIEWS

Executive Summary

BIO believes FDA could outsource activities in the areas of lot inspections and lot release for biologicals, according to discussions by the association preliminary to development of FDA reform proposals. The Biotechnology Industry Organization board reviewed a series of memos suggesting FDA reforms at its Feb. 8 meeting.

Latest Headlines
See All
UsernamePublicRestriction

Register

PS025713

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