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

Special Counsel Finds US FDA’s Dismissal Of Inspection Concerns Unreasonable

Executive Summary

Agency biologics investigator questioned site classification downgrades and belated response to Merck & Co. plant informant’s concerns.

You may also be interested in...



Merck’s COVID Manufacturing Deal With US Government Goes Well Beyond J&J Vaccine

‘Wartime’ contract with BARDA will fund up to $268.8m in production site upgrades so Merck can also produce other COVID-19 vaccines and therapeutics as needed.

Why Data Integrity Concerns Led Fresenius To Back Away From Akorn Deal

Tipped off by whistleblower, Fresenius reviewed data integrity audits that led it to back away from plans to acquire Akorn, firm tells court. It’s a case with lessons for any pharmaceutical company that wants to ensure its own data integrity – and that of its business partners.

Revised US Approach For Parenteral Drug Leachables Could Prevent Regulatory Missteps

Broad agreement across US FDA on modified PQRI recommendations could reduce approval delays over risk of chemicals leaching into parenteral drugs.

Topics

Related Companies

UsernamePublicRestriction

Register

PS144100

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