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

CDER lists guidances in the works for 2009

This article was originally published in The Gold Sheet

Executive Summary

FDA's Center for Drug Evaluation and Research has listed several drug quality-related documents on its guidance agenda for 2009, including ones in the chemistry category for: CMC postmarketing plans, annually reportable CMC post-approval changes, assay development for immunogenicity testing, immunogenicity assessment for therapeutic protein products, incorporation of physical-chemical identifiers into solid oral dosage forms for anti-counterfeiting, and standards recognition. In the compliance category, CDER is developing guidances on contract manufacturing, dosage delivery devices for OTC liquids, non-penicillin beta-lactam contamination, Part 11 electronic records, positron emission tomography cGMPs, pharmaceutical component quality control, pharmaceutical components at risk for melamine contamination, pharmaceutical manufacturing statistics, pre-launch activities importation request, and process validation general principles and practices

You may also be interested in...



QUOTED. 22 September 2020. Francis deSouza.

Illumina announced on 21 September it will buy back Grail, which is planning to commercialize its multi-cancer early detection blood test Galleri in 2021. See what Illumina’s CEO Francis deSouza said about it here.

Gottlieb vs Azar vs Califf vs Gottlieb: The Public Fight Over How The US FDA Should Operate

Yes, Gottlieb’s in there twice; things get complicated when an agency starts to lose credibility.

Amgen’s KRAS Inhibitor Shows Durability; Pivotal Data Possible This Year

Newly published data and results presented at ESMO for Amgen’s sotorasib (AMG 510) show relatively long-lasting responses and progression-free survival in lung cancer. 

UsernamePublicRestriction

Register

ID1122310

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