Pink Sheet is part of the Business Intelligence Division 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

In Final Guidance On Residual Solvents, FDA Allows Control, Not Just Testing, Verification

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency accepts industry comments on testing issue, but document may still contain hurdles for approval of some generic drugs.
Advertisement

Related Content

FDA Offers More Flexibility on Residual Solvents in Generic Drug Applications
Generic Firms Object To Policy Behind Residual Solvents Deficiency Letters
Generic Firms Object To Policy Behind Residual Solvents Deficiency Letters

Topics

Advertisement
UsernamePublicRestriction

Register

PS068806

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