Accelerated Approval Could Expand As Alternative To Progressive Approval
CDER Director Woodcock says agency should issue internal and external guidance to promote consistent use of the pathway.
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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.
Former FDA attorneys laud her appointment, saying she is highly regarded inside and outside the agency for her intelligence, warmth and expertise on Hatch-Waxman and other key issues.
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.