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03 August 2021
The Senate Appropriations subcommittee that oversees funding for the US Food and Drug and Administration advanced a bill that would give a $200 million boost in budget authority to the agency in FY2022.

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03 August 2021
Despite the decades of experience with FDA’s risk-based regulatory system, better data are needed to understand what benefits approved or cleared medical devices have provided to patients, Darrow said. “In the case of 510(k) submissions, the under...
03 August 2021
Australia’s Therapeutic Goods Administration (TGA) has published its international engagement strategy for 2021 to 2025. The document details TGA’s plans to collaborate on the creation of a more globally aligned regulatory framework to reduce the ...
03 August 2021
The US Food and Drug Administration has warned New York - based pharmaceutical manufacturer Syntec for a litany of good manufacturing practice (GMP) problems. The agency says that issues related to how the firm handles active pharmaceutical ing...