FDA is ready to bring patient voices and perspectives into the drug approval framework. Practically, that means that drug sponsors will have to develop new skills and structures for working with a familiar stakeholder group at an unfamiliar point in the drug development process. The new challenge was a major theme at PhRMA’s 2012 Annual Meeting.
Think of pharma’s new outreach to patient groups as Patient Advocacy 3.0 – a new set of relationships designed to impact the early stages of drug development by defining the targets and criteria for drug review and approval by the Food & Drug Administration.
Patient Advocacy 1.0 stretches back about twenty five years to the early push for accelerated approval approaches for HIV treatments,...
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
