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 Botanical Review Team To Implement Herbals Guidance, MaPP

This article was originally published in The Tan Sheet

Executive Summary

The newly formed Botanical Review Team in FDA's Office of New Drugs is intended to "consolidate OND's scientific and regulatory expertise in botanical products," according to a Feb. 20 agency announcement

You may also be interested in...



FDA Botanical Drug Products Final Guidance Stresses Batch Consistency

An FDA final guidance on botanical drug products includes new language recommending that firms demonstrate "batch-to-batch consistency" for botanical drug candidates through the clinical development process prior to submitting an NDA

FDA Botanical Drug Products Final Guidance Stresses Batch Consistency

An FDA final guidance on botanical drug products includes new language recommending that firms demonstrate "batch-to-batch consistency" for botanical drug candidates through the clinical development process prior to submitting an NDA

FDA Botanical Drug Products Final Guidance Stresses Batch Consistency

An FDA final guidance on botanical drug products includes new language recommending that firms demonstrate "batch-to-batch consistency" for botanical drug candidates through the clinical development process prior to submitting an NDA

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS095159

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