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

Schering back in good graces

Executive Summary

Schering-Plough completed all 212 significant steps and 30 validation actions required under its manufacturing consent decree by its deadline of Dec. 31, 2005. The goal was reached on time, as the company had anticipated (1"The Pink Sheet" Nov. 14, 2005, p. 28). The consent decree's obligations and requirements are subject to certification by an external third party and review and approval by FDA...

You may also be interested in...



Schering exits manufacturing consent decree

Schering-Plough's petition to dissolve the manufacturing consent decree it has been operating under since May 2002 is granted by U.S. District Court for New Jersey. The company completed the requisite 212 significant steps and 30 validation actions to comply with current good manufacturing practices at the end of 2005 (1"The Pink Sheet" Jan. 09, 2006, In Brief). FDA did not oppose the company's petition, according to Schering...

Schering To Wrap Up Consent Decree Major Steps, Validations By Year-End

Schering-Plough aims to complete certain major requirements under its manufacturing consent decree by the end of 2005, but intends to extend lessons learned from the process to other parts of its business

Speedy Approval Of Gilead’s Veklury Sets Stage For Pediatric Expansion, Dosing Refinement

US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.

UsernamePublicRestriction

Register

ID1131516

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