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Accelerated Approval Expansion Proposals Pending, But One Needs An Overhaul

Executive Summary

ULTRA bill will need changes to gain the support of influential patient group. Meanwhile, BIO is circulating a proposal to make changes to existing regulations.

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“Adaptive Licensing” Proposals View REMS As Answer To Limited Evidence

Some ideas for new drug approval pathways seem to envision the use of Risk Evaluation and Mitigation Strategies as a means for preventing and monitoring off-label use following initial approval, apparently without regard to the seriousness or extent of a product’s risks. Given the burdens currently created by REMS, any effort to expand and retrofit the programs to a new approval pathway is likely to draw pushback from the health care community.

Accelerated Approval Legislation Picking Up Speed; ULTRA Becoming FAST

Revisions to the House bill make it nearly identical to sections of Sen. Kay Hagan’s legislation. The debate on PDUFA add-ons will be rejoined at a Commerce Committee hearing, but TREAT now has considerable momentum.

Coverage With Evidence Development and Expedited Approvals: Policy Proposals For FDA and CMS

Based on stakeholder consultations, former FDA and CMS head Mark McClellan and former CMS official Sean Tunis present a potential upside for biopharma in broader use of Medicare coverage with evidence development. Pfizer executives participate in workshop on coordinating expedited drug approval, CED policies.

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