Pink Sheet 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

FDA says PET cGMP rule coming soon

This article was originally published in The Gold Sheet

Executive Summary

FDA expects to publish a final rule this August on cGMP requirements for position emission tomography (PET) products, according to the semi-annual regulatory agenda of the Health and Human Services Department, published in the May 5 Federal Register. Section 121 of the FDA Modernization Act of 1997 directs FDA to establish cGMPs for these medical imaging drugs. The regulation would establish minimum standards for the production and testing of these products that would reflect their unique characteristics
UsernamePublicRestriction

Register

PS000247

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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