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 MAPP describes roles and responsibilities in reviewing quality portions of BLAs

This article was originally published in The Gold Sheet

Executive Summary

FDA's Center for Drug Evaluation and Research has issued a policy guide that outlines the roles of different organizations in reviewing the quality sections of new biologics license applications and supplements. It addresses the responsibilities of the Office of Biotechnology Products (OBP) in the Office of Pharmaceutical Science (OPS) and the Division of Manufacturing Product Quality (DMPQ) in the Office of Compliance in reviewing these applications. The MAPP is meant to "provide a team approach to product quality evaluation of biologics licensing application, and defines clear roles and responsibilities." For example, the DMPQ assessment lead is responsible for microbial method qualification and the OBP assessment lead is responsible for overall process design and flow for the drug substance and the non-sterility parameters of the drug product. The MAPP took effect on Dec. 22 and the policy will be re-evaluated after one year

You may also be interested in...



Woodcock launches quality systems initiative for CDER

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, says her top priority this year is to launch an overall quality system for the center. "This will result in appreciable improvements in consistency of our regulatory approach over time," she told the WCBP Symposium on Jan. 25 in Washington

Roche/Genentech Keeps Commitment To External Cancer Innovation

Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.

US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials

To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.

UsernamePublicRestriction

Register

OM009724

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