Social Media Data Gains Prominence In Patient-Focused Drug Development
FDA guidances have provided ‘major step forward’ for use of social media data, Roche researcher notes. Agency staffer offers checklist for collecting patient experience data in this realm.
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Patient-Focused Drug Development Guidance: Determining When A Clinical Outcome Assessment Is Appropriate
A US FDA draft guidance on selecting and developing fit-for-purpose clinical outcome assessments specifies the evidence that can be provided to support using a COA in a particular context.
Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.
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.