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Not Another FDAAA – Observers Expect Fewer FDA Reforms In PDUFA V

Executive Summary

Congress is not expected to pile as many new responsibilities on FDA in the upcoming Prescription Drug User Fee Act reauthorization as in 2007’s FDA Amendments Act.

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Post-Market Safety Updates Replaced By “Periodic Benefit-Risk Evaluation Reports”

Draft guidance from FDA would adopt the International Conference on Harmonization’s periodic benefit-risk evaluation reports, which will offer sponsors the opportunity to provide updates on benefit information along with safety signals to the regulatory authorities.

Congress Mulls Adding “Economic Growth” To FDA Mission Statement

As PDUFA hearings start, Commissioner Hamburg says considering the jobs affected by the approval or denial of an application would be difficult and inappropriate. Rep. Rogers and Sen. Coats author bills to require changing FDA’s mission statement in program renewal.

Congress Mulls Adding “Economic Growth” To FDA Mission Statement

As PDUFA hearings start, Commissioner Hamburg says considering the jobs affected by the approval or denial of an application would be difficult and inappropriate. Rep. Rogers and Sen. Coats author bills to require changing FDA’s mission statement in program renewal.

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