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

Sponsors Fail To Win US FDA Endorsement For Trimming Trials During Pandemic

Executive Summary

Agency more interested in switching to remote methods or imputing data than reducing sample size or duration of cell/gene therapy trials, official tells ASGCT.

You may also be interested in...



US FDA Acknowledges API Manufacturers’ GMP Recordkeeping Burden

Agency acknowledged burden regulations for implementing GMP provisions of FD&C Act placed on API manufacturers in regulatory burden notice.

PIC/S Wants To Know: What About ‘Authorized Persons’ For Batch Release Outside The EU?

International association of pharmaceutical inspectorates launches industry consultation on aligning with the one EU GMP provision it spurned years ago.

Memo To File: How US FDA Decided Which Janssen Vaccine Drug Substance Batches Were OK To Use

Two batches were authorized because they were made before production waste jammed Emergent BioSolutions' Bayview plant.

Topics

UsernamePublicRestriction

Register

PS144319

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