FDA’s Robyn Bent On The Evolution of Patient-Focused Drug Development
The director of the agency’s patient-focused drug development program talks to the Pink Sheet about how the program has improved the development and evaluation of new drugs, initiatives underway, and plans to standardize and harmonize the process.
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PTO judge says she is ‘intrigued’ by request for patients to be involved in patent discussions and examiner training. Patients advocated for a seat at the table during USPTO-FDA’s ‘listening session’ on initiatives to promote greater access to medicines.
Patient-Focused Drug Development Grants May Be Program’s ‘Most Significant’ Accomplishment Since 2019
US FDA has issued five grants for development of standard core clinical outcome assessments and related endpoints that can be used across disease areas and may produce more reliable data for regulatory decision-making.
Patent office could request information from FDA that is material to patentability, speakers at USPTO-FDA ‘listening session’ advise the agencies. Information exchange raises questions about trade secret protection and burdens on agencies.