Tag: Reviewing

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

By iwano@_84

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

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Facebook’s Oversight Board Will Start Reviewing Content Soon

By iwano@_84

Facebook’s  (FB) – Get Report independent oversight board may start to review content on its platforms starting next month, media reports suggest.

Both CNBC and the Financial Times reported on the development Thursday.

The independent body that will review Facebook’s decisions about what content to take down or leave up, will start accepting cases in mid to late October, weeks before the presidential election, a spokesperson for the board confirmed.

“We are currently testing the newly deployed technical systems that will allow users to appeal and the Board to review cases. Assuming those tests go to plan, we expect to open user appeals in mid to late October,” the oversight board said.

The oversight board will rule on appeals from Facebook and Instagram users and questions from Facebook itself.

It remained unclear if the Supreme Court-style oversight board will be able to act on complaints related to the

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