Global Pharma Guidance Tracker – August 2022
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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A full appraisal by the UK cost watchdog is not the only way to gauge the safety and effectiveness of Evusheld, argues the independent Drug Safety Research Unit in response to the government’s decision not to buy the licensed COVID-19 drug because of insufficient data on protection.
EU regulators have developed a draft good practice guide explaining how stakeholders can make use of the Metadata Catalog of RWD Sources, which is expected to be released in late 2023, to identify appropriate sources for specific research questions.
An updated Q&A on the EU Clinical Trial Regulation distinguishes between patient-facing documents and recruitment material to clarify in which sections of the trial application these should be submitted. It also underlines the main principles to consider for transitioning studies from the Clinical Trials Directive to the CTR.