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A US FDA draft guidance on selecting and developing fit-for-purpose clinical outcome assessments specifies the evidence that can be provided to support using a COA in a particular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.
Agency staff note hurdles in obtaining evidence outlined in FDA’s patient-focused drug development guidance to support regulatory decision-making.
Teva to pay $4.25bn over 13 years under agreement in principle with 12 state attorneys general, Native American tribes and plaintiffs’ lawyers. Previous settlement offer provided mostly medication. Deal is contingent on governments signing on and Allergan inking settlement.