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

Generic drug impurities draft guidance

Executive Summary

FDA releases draft guidance entitled "ANDAs: Impurities in Drug Substances." The document, published in the Federal Register Jan. 31, is the first revision of the original 1999 guidance. The draft guidance suggests companies use stability studies, chemical development studies and routine batch analysis to test for impurities, which can be qualified in four ways...

You may also be interested in...



ANDA Impurity Product Specifications Updated In FDA Draft Guidance

A revised FDA draft guidance updates recommendations on the listing and qualification of degradation products in ANDAs

DJO Thinks Trilliant Is Brilliant, Announces Acquisition

DJO Global will buy Trilliant Surgical to further its ongoing expansion into the US foot and ankle market.

Legend Biotech CEO Ying Huang On Moving Fast In the BCMA CAR-T Race

Ying Huang was named CEO as his predecessor came under investigation in China and as partner Janssen was getting closer to seeking US FDA approval for its lead CAR-T therapy.

Topics

UsernamePublicRestriction

Register

GB140150

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