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

US FDA Assesses Over 500 Biopharma Plants Remotely Via Records Review; Refines Process

Executive Summary

Agency may share outcomes of remote record reviews in lieu of inspections at US and foreign facilities.

You may also be interested in...



Approval Of BMS/Bluebird’s Ide-Cel May Come Just In Time

In last year’s acquisition, Bristol Myers Squibb agreed to pay Celgene investors another $9 per share based on three approvals, including idecabtagene vicleucel (bb2121) by 30 March 2021.

How FDA Will Use Its New Authority against Denying, Limiting or Refusing Inspections – And Why Industry is Still Worried

How will FDA use its recently drafted guidance against obstructing inspections? Industry fears it may depend on how individual investigators interpret terms like “reasonable.”

US Buy Of Lilly’s COVID-19 Therapy Now Turns On FDA's Manufacturing Quality Assessment

Under pressure to authorize use of Lilly’s bamlanivimab, the FDA must first weigh efficacy signals and GMP plant remediation progress.

Topics

UsernamePublicRestriction

Register

ID1132356

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