Tag: Regulatory

Five new Mac models pop up in regulatory documents, suggesting imminent release

By iwano@_84

An international regulator is showing five unannounced Apple Mac models running macOS Big Sur, although unusually, the new listing also includes multiple Macs and iOS devices that have previously been registered.

Four new entries in the Eurasian Economic Commission’s regulatory database together list a total of 64 Apple devices — though only five have not appeared before. It’s unusual to see so many re-listings, and the EEC database does not explain them, but the new devices are required to be listed before they can go on sale.

All five of the entirely new entries are Macs listed, in translation, as “personal computers of the Apple trademark, and spare parts for it.” They are running “macOS software version 11.0.” These new devices have the model numbers A2348, A2438, A2439, A2337, and A2338.

Also listed and not yet released are Macs with macOS Big Sur model numbers A2147, A2158, and A2182. These

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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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