PRESS RELEASE

FDA renews its use of Certara software to facilitate new drug and biologics regulatory review

Certara has 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.

FDA has renewed its use of Synchrogenix’s electronic Common Technical Document (eCTD) review software, GlobalSubmit REVIEW, providing enterprise-wide use at both 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 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 Labelling submissions following the eCTD standard. FDA also uses GlobalSubmit VALIDATE to process and validate eCTD submissions. The agency selected GlobalSubmit in 2005 when it began its eCTD initiative.

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 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 FDA use Certara’s Phoenix pharmacometrics software for internal research and to independently analyse, verify and complete the review of sponsor IND, BLA, NDA, ANDA and other submissions.  

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, 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 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.’

The aforementioned contract awards are HHSF223201850063A, HHSF223201820140A, and HHSF223201810279P.

Company: 
Feature

Robert Roe reports on developments in AI that are helping to shape the future of high performance computing technology at the International Supercomputing Conference

Feature

James Reinders is a parallel programming and HPC expert with more than 27 years’ experience working for Intel until his retirement in 2017. In this article Reinders gives his take on the use of roofline estimation as a tool for code optimisation in HPC

Feature

Sophia Ktori concludes her two-part series exploring the use of laboratory informatics software in regulated industries.

Feature

As storage technology adapts to changing HPC workloads, Robert Roe looks at the technologies that could help to enhance performance and accessibility of
storage in HPC