Tag: reviewing

01
Oct
2020
Posted in software

Food and Drug Administration Renews and Expands Use of Certara’s Biosimulation Software for Reviewing Regulatory Submissions

FDA’s Office of Pharmaceutical Quality adds new licenses of Simcyp Simulator

Certara, a global leader in biosimulation, today announced that the U.S. Food and Drug Administration (FDA) has again renewed and expanded its licenses of Certara’s biosimulation software, with more than 400 user licenses of Simcyp™ and Phoenix™ platforms. Eleven divisions and offices of the FDA use Certara’s software for internal research and to independently analyze, verify, and review regulatory submissions.

Certara’s Simcyp Simulator, an industry-leading platform for physiologically-based pharmacokinetic (PBPK) modeling and simulation, is used to determine first-in-human dose, design more efficient and effective clinical studies, and predict drug-drug interactions using virtual populations. The FDA’s Office of Clinical Pharmacology has renewed its licenses for the Simcyp Simulator, including Simcyp Pediatric and the Simcyp Cardiac Safety Simulator. Furthermore, the FDA’s Office of Pharmaceutical Quality recently ordered Simcyp user licenses, expanding the FDA’s use of the platform. The agency uses Simcyp software to independently analyze, verify, and review sponsor IND, BLA, NDA, ANDA, and other submissions.

“Regulators around the world rely on our sophisticated software to inform their reviews of regulatory submissions,” said Rob Aspbury, Ph.D., president of the Simcyp division at Certara. “It is a privilege to continue partnering with the FDA to demonstrate the ever-increasing uses of PBPK modeling to optimize drug development and support the regulatory review process in an effort to bring safe and efficacious therapies to market.”

Additionally, the FDA has renewed its user licenses of Certara’s Phoenix Platform, a comprehensive and widely-used software for pharmacokinetic, pharmacodynamic, and toxicokinetic modeling and simulation. Eleven divisions and offices at the FDA, along with ten other global regulatory agencies such as Japan’s Pharmaceuticals and Medical Devices Agency and China’s National Medical Products Administration, use the Phoenix Platform to evaluate regulatory submissions.

Certara’s customers use Phoenix extensively

29
Sep
2020
Posted in internet

CRTC to keep wholesale internet rates steady while reviewing decision to slash prices



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© Provided by The Canadian Press


TORONTO — Bell Canada and several cable companies including Rogers Communications will be able to keep their wholesale internet rates as they are while the federal telecommunications regulator reviews its decision to cut them.

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The companies have been battling the 2019 CRTC decision to slash what network operators can charge independent internet service providers (ISPs).

The federal cabinet and Federal Court of Appeal have both refused to overrule the CRTC’s decision, but noted the federal regulator is doing its own review of the decision.

Canada’s largest independent internet company, TekSavvy, and its industry association have argued the new, reduced rates should be implemented.

The independent ISPs argue the wholesale prices have been set too high since 2016 and prevent them from lowering retail rates for their customers.

However, the telecommunications regulator said Monday that Bell and the cable carriers met the requirements to obtain a stay of the August 2019 order.

This report by The Canadian Press was first published Sept. 29, 2020.

Companies in this story: (TSX:BCE, TSX:RCI.B, TSX:CCA, TSX:QBR.B)

The Canadian Press

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