• FDA Renews and Expands Its Use of Certara Software to Facilitate New Drug and Biologics Regulatory Review

    • October 12, 2018
    • Posted By : admin
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    Certara®, the global leader in model-informed drug development, regulatory science, market access and real-world evidence solutions, today announced that the US Food and Drug Administration (FDA) has renewed, and in many cases increased, its number of Certara software licenses for reviewing new drug and biologics applications.

    The FDA has renewed its use of Synchrogenix’s electronic Common Technical Document (eCTD) review software, GlobalSubmit REVIEW™, providing enterprise-wide use at both the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) divisions. Synchrogenix is Certara’s regulatory science division.

    The FDA has stated that “it is aggressively moving towards an electronic regulatory submission to streamline the regulatory review process.” GlobalSubmit REVIEW is being used by the FDA to review New Drug Application (NDA), Biological License Application (BLA), Abbreviated New Drug Application (ANDA), Investigational New Drug (IND), Drug Master File (DMF), Annual Period Safety Report, and Advertising and Promotional Labeling submissions following the eCTD standard. The FDA also uses GlobalSubmit VALIDATE™ to process and validate eCTD submissions. The agency selected GlobalSubmit in 2005 when it began its eCTD initiative.

    The FDA has increased its use of Certara’s Phoenix software platform to nearly 400 users, which includes Phoenix WinNonlin®, non-linear mixed effects (NLME™), in vivo-in vitro (IVIVC), Connect, Trial Simulator™ and training. Certara’s relationship with the FDA dates back to 2001, when its previously named Pharsight division formed a Cooperative Research and Development Agreement (CRADA) with the agency’s CDER division. Today, nine offices within the FDA use Certara’s Phoenix pharmacometrics software for internal research and to independently analyze, verify and complete the review of sponsor IND, BLA, NDA, ANDA and other submissions.

    The FDA has also renewed its licenses for Certara’s physiologically-based pharmacokinetic (PBPK) Simcyp Population-based, Pediatric, Animal, and Cardiac Safety Simulators. The agency, which has been an associate member of the Simcyp Consortium since its inception in 2001, also uses Simcyp software to independently analyze and verify the review of sponsor IND, BLA, NDA, ANDA and other submissions. Additionally, the FDA has awarded several grants to Simcyp and has renewed its CRADA with the company to create canine models to help streamline veterinary drug development and evaluation.

    “We are proud of our long history of partnering with the FDA to optimize the drug development and regulatory review processes,” said Certara CEO Dr. Edmundo Muniz. “The FDA Commissioner has been an outspoken advocate for the use of innovation, and electronic technologies to advance the delivery of safer, more effective medicines for patients. For example, Dr. Gottlieb recently stated: ‘I want to highlight one example of these steps, which we’re investing in, and will be expanding on, as part of our broader innovation initiative. It’s the use of in silico tools for improving drug development and making regulation more efficient.’ Certara continues to support this approach by providing ongoing education, training and collaboration initiatives for the industry.”

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