India's Patent Policy Needs More Stakeholder Input, US Trade Office Urges
'Watch List' from USTR also objects to China's definition of 'new drugs'; PhRMA criticizes practices in Canada and Columbia.
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US Trade Representative also highlights restrictive patentability criteria in Canada, India and Indonesia in its annual Special 301 report.
Operation Warp Speed confirmed the necessity of having a facility on hand to develop and manufacture a vaccine for the next crisis, the outgoing advisor says.
Broader use of adaptive trial designs and master protocols, checklist-based application review, and enhancement of real-world monitoring of products are among the recommendations of US FDA's COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) report, an effort months in making based on interviews with agency management, staff, and outside stakeholders.