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

US FDA Role In Biomanufacturing Initiative Largely Packages Ongoing Works

Executive Summary

The White House ‘Biotechnology’ initiative is very broadly focused, with non-health sectors receiving the bulk of the attention. The US FDA’s role is small – but it could further boost attention to efforts to encourage adoption of advanced manufacturing.

You may also be interested in...



COVID-19 Outlook: Variants, Boosters, And Being ‘Worse Off’ For Next Pathogens

US FDA’s Peter Marks, Pfizer’s Mikael Dolsten and other experts discuss what is being done to prepare for the future, worries about higher fatality rates, and what 2023 might look like.

Cross-Strait Taiwan Tensions, COVID, And Clinical Trials: An Interview With TLC President Yeh

A recent survey showed healthcare as among the sectors US companies were most concerned about amid the ongoing China-US tensions over Taiwan. But how do biotech firms on the island itself view the current situation? We spoke to the president of one amid Taiwan’s imminent reopening.

US FDA Limits GMP Exemption For ‘N of 1’ Investigational New Drugs

Agency drafts guidance on how to apply requirements for chemistry, manufacturing and controls, and for good manufacturing practices, to bespoke antisense nucleotides.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS147001

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