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

CDER’s Novel Approvals In 2012

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The Center for Drug Evaluation and Research cleared 32 new molecular entities and seven novel therapeutic biologics in 2012. The Center for Biologics Evaluation and Research approved six new biologic entities, bringing the total across FDA to 45 new agents.

You may also be interested in...



QUOTED. 24 September 2020. Colleen Kraft

Cognoa said it will submit its AI-powered digital app for early detection of autism for de novo clearance with the US FDA. See what the company’s senior medical director of clinical adoption said about it here.

Remdesivir’s Path To Orphan Designation Could Be Exploited By Others, Experts Warn

Congress should give FDA more flexibility to administer orphan designations, such as the ability to revoke designations later if the disease prevalence grows beyond the rare disease threshold.

‘March In’ Plan Unveiled By Democratic Think Tank: A Battle Biopharma Would Welcome?

In sign of how much has changed in four years, industry might be better off if Biden takes CAP’s advice and launches ‘march-in’ actions to address pricing of COVID products.

Topics

UsernamePublicRestriction

Register

PS045148

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