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Australia’s Therapeutic Goods Administration (TGA) is getting a digital makeover, after the federal government announced on Friday it would invest AU$12 million over four years to make it happen.

As part of the revamp, TGA’s business systems and infrastructure will be digitised and cybersecurity measures will be bolstered.

Specifically, it will enable medical companies to use automatic data transfer to deliver drug reaction reports on patient safety from their own internal databases into the TGA Adverse Events Management System (AEMS) database, saving up to 15 minutes per report. This will be a change to the current process that requires reports that are submitted in PDF format, as well as other formats, to be manually entered into the database. 

See also: ADHA details My Health Record breach attempt

Minister for Health Greg Hunt touted the revamp would help cut red tape for more than 4,000 businesses that apply to register medicines

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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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Updated

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After that point, the White House will take additional steps to ban the app from all U.S. users. President Trump has said he would back off the ban if TikTok, which he views as a security risk, is sold to a U.S. owner (Oracle and Walmart are bidding for it) and ByteDance divests itself completely from the company.

It’s unclear what grounds Nichols ruled on. His opinion will be unsealed later today after both parties have a chance to review it for sensitive information. 

TikTok’s lawyers argued during the Sunday hearing that a ban on downloads would irreparably harm its business and the action was unnecessary as it tries to iron out a deal that meets White House approval. The Justice Department argued that a ban on downloads would leave TikTok’s business largely intact while preventing any new users from potentially putting their data at risk.

The Justice Department says

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Targeting China’s tech companies is now the norm.

Targeting China’s tech companies is now the norm.
Photo: Thomas Peter-Pool (Getty Images)

The Trump administration has another Chinese technology company on its radar: the Semiconductor Manufacturing International Corporation, the country’s biggest chip maker. And as you all can imagine if you’ve been following the recent news cycle, that is not good for SMIC.

On Friday, the U.S. Department of Commerce informed American companies in the chip industry of new restrictions on exports to SMIC, the Financial Times reported. Now, American companies must obtain licenses from the government in order to sell products, such as software and chip-making equipment, to SMIC.

In a letter communicating the new restrictions to U.S. companies, the Commerce Department said that it had taken action because exports to SMIC posed an “unacceptable risk” of potentially being used for military purposes.

According to U.S. government sources quoted by the Times, the

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