From the US FDA’s ISTAND Program to EU’s Melloddy Initiative, and from the global challenges of real-world data to the opportunities in India, Parexel’s EVP for Clinical Data and Digital Services, chief strategy officer and India head speak on a range of topics in this interview with the Pink Sheet.
In a world where pharmaceutical companies are expanding their commercial footprint across borders and where product pricing is coming in for greater scrutiny on home turf, the role of regulatory harmonization in keeping trial and drug approval costs lower is being closely followed.
The Pink Sheet regularly speaks to industry stakeholders on such issues and recently sat down with executives at Parexel...
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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.
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
