Master protocol for Phase I/II screening trial could make development more efficient, but concerns about regulatory obligations, lack of registrational intent and infrastructure complexity – as well as firms' willingness to share – may be hurdles to participation.
Master protocols could allow pediatric cancer trials to become a more proactive and efficient drug development exercise rather than the regulatory-driven, reactive approach that has long guided investigation of new oncologic agents for use in children and adolescents.
However, the ability to accomplish this task may depend upon a number of factors, including the willingness of sponsors to...
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A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.
