Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 BioPharma Services Awarded FDA Contract | Contract Pharma

What are you searching for?

Sign in
Breaking News

BioPharma Services Awarded FDA Contract

Spans 5-years and is worth $20 million

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

BioPharma Services USA has been awarded a 5-year, $20 million contract with the Center for Drug Evaluation and Research (CDER), a division of the US Food and Drug Administration (FDA). The contract is to conduct in vivo studies of generic drug products in human subjects over a period of five years, from 2016 through to 2021.

“We are very proud to work with the FDA in support of their generic drug programs. This award is a great example of BioPharma’s capabilities as a leading industry expert in bioequivalence and early stage clinical research,” said Renzo DiCarlo, chief executive officer, BioPharma Services.

The FDA studies conducted by BioPharma will allow CDER to address scientific questions in developing generic approval standards and ensure post-market safety and efficacy of approved generic drug products. Ultimately, the goal of these studies is to help improve the generic review practice within CDER. As part of this contract, BioPharma will provide the FDA with a full service offering from study design inception to clinical conduct, bioanalysis and final report.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics