BioPharma Services USA awarded a 5 Year, $20 million contract with the FDA
The contract is to conduct in vivo studies of generic drug products in human subjects from 2016 through to 2021.
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 FDA. The contract is to conduct in vivo studies of generic drug products in human subjects over a period of 5 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, CEO at BioPharma Services, Inc.
The FDA studies conducted by BioPharma will allow CDER to proactively address scientific questions in developing generic approval standards and ensure post-market safety and efficacy of approved generic drug products. Ultimately, the outcome of these studies will 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.
Brent Matthews, COO at BioPharma Services added: "I am certain that our outstanding regulatory history with the FDA and our team’s extensive expertise in the conduct of bioequivalence trials played a major role in landing this important contract with the FDA.”
Related News
-
News Federal judge blocks Colorado's unprecedented price cap on Amgen's Enbrel
A US federal court has halted Colorado's attempt to impose a US$31,200 annual price cap on Amgen's arthritis drug Enbrel, ruling that the pharmaceutical company would likely suffer irreparable harm. The decision represents a significant blow to... -
.png)
News Protecting life-saving therapies: CPHI Online Podcast Series
The latest episode of the CPHI Podcast Series dives into a critical challenge facing the pharmaceutical industry: ensuring the integrity of temperature-sensitive medications and biologics through advanced predictive technology.
-
News 2026 Outsourcing Outlook Update - pharma at a crossroads
The pharmaceutical contract development and manufacturing organisation (CDMO) sector is experiencing unprecedented transformation, driven by evolving therapeutic complexities, geopolitical tensions, and the growing demand for specialised manufacturing ... -
News Roche maintains German investment commitment whilst rivals scale back
Pharmaceutical giant Roche has reaffirmed its commitment to investing in Germany, standing firm even as competitors Eli Lilly and Boehringer Ingelheim dramatically reduce their planned investments in response to controversial healthcare reforms.
-
News Women in Pharma: The History of CPHI Women in Japan
Our monthly Women in Pharma series highlights the influential lives and work of impactful women working across the pharmaceutical industry, and how the industry can work towards making the healthcare industry and workplace more equitable and inclusive. -
News EU drafts deal to end essential medicines shortage
European negotiators have agreed new legislation to tackle persistent shortages of essential medicines by prioritising supply security over price in public procurement and supporting domestic pharmaceutical manufacturing with strategic funding.
-
News Thermo Fisher Scientific offloads microbiology business to PE firm Astorg
The life sciences giant is divesting its global microbiology unit, which generated $645 million in revenue last year, to the pan-European private equity firm as part of an active portfolio management strategy. The transaction is expected to close in th... -
News The Shift: Why Sustainability is Moving to the Centre of CPHI Milan 2026
CPHI Online contributor David Roach takes a look at how conversations around sustainability in the pharmaceutical industry can and must be transformed into actionable deliveries, and what the inaugural CPHI Sustainability Summit means for the industry.