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 Develops Separate Set Of GMP Requirements For PET Drug Makers

Executive Summary

FDA will require commercial manufacturers of approved positron emission tomography drugs to meet new GMP requirements by Dec. 12, 2011. This marks the first time that FDA has mandated separate GMPs for a particular type of drug product

You may also be interested in...



PET Drugs Without An IND Get Three More Years For Studies Under FDA Guidance

Q&A document from agency says sponsor does not have to use the same manufacturing process as the reference listed drug.

FluoroPharma’s Bet On Next-Gen Molecular Imaging Agents

Molecular imaging’s technological advances are impressive, but getting the business model right and investors on board has been hard for start ups in the field. FluoroPharma CEO Thijs Spoor believes his company, which has several cardiovascular imaging agents in clinical trials, is on the right track and ripe for partnerships.

Supply Chain GMP Rewrite, Guidance Documents in Works at FDA

FDA is continuing to draft a regulation for strengthening supply chain controls that he had announced in June 2010, Brian Hasselbalch of the agency’s center for drugs told a Parenteral Drug Association conference last month.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS051779

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