Australia's TGA To Publish Details Of New Drug Applications
More Transparency To Address Stakeholder ‘Frustration’
A lack of information on innovative new drug filings and issues with late notification of generic and biosimilar drug applications have led the Australian authorities to introduce some new rules starting next year.
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With product shortages made worse by the pandemic, companies in the UK are being asked to use a new system for notifying potential supply disruptions and any plans to discontinue specific medicines.
Two new projects have begun, one on standardizing the assessment of immune responses in individuals vaccinated in clinical trials, the other to improve understanding of potential immunity in patients who have been infected with SARS-CoV-2.