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The agency will offer $35 million in funding over the next five years, on research that aims to modernize manufacturing and quality assurance and control (QA and QC) practices.
FDA has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE) a grant that would support initiatives designed to improve pharmaceutical manufacturing and quality assurance practices, and deepen the industry’s scientific knowledge base. Plans call for FDA to fund up to $35 million over the next five years. The agency has been funding such efforts at NIPTE, a consortium of 17 universities, since 2011.
“The funding allows NIPTE faculty to contribute their research expertise, helping the FDA create policies in critical areas such as quality by design of complex pharmaceutical products, characterization of pharmaceutical materials, and formulation strategies like abuse deterrent products to combat opioid abuse,” said Vadim Gurvich, executive director of NIPTE, research associate professor at the University of Minnesota, and principal investigator on the grant, in a press release. “In addition, NIPTE will address such topics as using quality metrics and using a quality scorecard to improve surveillance and risk-based decisions.”
“This brings our decade-long collaboration with the FDA to the next level, allowing us to make a bigger impact on quality, safety, and affordability of pharmaceutical products,” said Ajaz Hussain, president of NIPTE, in a press release. “NIPTE's academic collaboration has matured and is at the threshold to take on the additional responsibility of being a voice of the pharmaceutical technology scientific community in the interest of patients and the American public.”
NIPTE is a non-profit organization whose aim it is to improve human health through multi-university collaborative research advancing quality, safety, affordability, and speed to market of medicines. Current members are: Duquesne University; Illinois Institute of Technology; Long Island University; Purdue University; Rutgers University; Texas A&M University; University of Connecticut; University of Iowa; University of Kansas; University of Kentucky; University of Maryland; University of Michigan; University of Minnesota; University of Puerto Rico; University of Rochester Medical Center; University of Texas; and University of Wisconsin.