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

ANDA Approvals May Be Hindered By New Elemental Impurities Requirements

Executive Summary

US FDA's generic approval total in January was dramatically lower than recent monthly tallies, raising questions about impact of requirements that took effect at beginning of the year.

Advertisement

Related Content

Gottlieb's 2018 Generic Drug Approval Goal May Be In Doubt
ANDA Median Approval Times Still Rising, But What Does It Mean?
ANDA Complete Responses Spike In FY 2018, But Why?
Manufacturing Regulatory Updates In Brief: Elemental Impurities, Class 3 Biowaivers, FDA Salt Policy
GDUFA II Reviews Start Strong With High First-Cycle Approval Rate
ANDA Reviews: First-Cycle Desired, But Two-Cycles OK?

Topics

Advertisement
UsernamePublicRestriction

Register

PS122485

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