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

Pharmaceutical Development CRADA, CMC Pilot Are Among Topics For Manufacturing Subcommittee Meeting

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Manufacturing Subcommittee will also address modernized good manufacturing approaches to process validation and International Conference on Harmonization quality topics.

You may also be interested in...



FDA Plans Pharmaceutical Development Focus Groups With Industry

Focus groups will examine development issues including information bottlenecks, quality systems and preclinical development.

FDA Postpones CMC Pilot Program Deadline

FDA has extended the deadline for its pilot program on the submission of chemistry, manufacturing & controls information in NDAs, according to a notice slated for publication in the Federal Register Sept. 19

FDA Antihypertensive Draft Class Labeling To Be Reviewed By Cardio-Renal Committee

FDA’s proposal for relabeling of antihypertensive agents is based on prior recommendations by the committee that information on cardiovascular outcomes related to blood pressure lowering be included as class labeling.

Topics

UsernamePublicRestriction

Register

PS063742

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