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FDA “Progressive Approval” And “Exceptional Approval” Pathways Possible Under Senate Bill

This article was originally published in The Pink Sheet Daily

Executive Summary

Legislation being drafted by Sen. Kay Hagan, D-N.C., would formalize FDA practices of approving drugs in certain circumstances where the evidence needed for a standard approval cannot be generated.

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PDUFA V Action Heats Up On Hill With House Hearings In February

An Energy and Commerce subcommittee will discuss the FDA and industry agreement on prescription drug user fees with FDA Commissioner Margaret Hamburg Feb. 1. Drug shortages will be part of the deliberations Feb. 7 when CDER Director Janet Woodcock goes before the panel to make the case for user fees on generic drugs and biosimilars.

Drug Shortage Bills Likely Drivers Of PDUFA Add-ons

Rep. Burgess says there appears to be enough bipartisan support for dealing with the shortage problem that it almost certainly will be added to the reauthorizing legislation.

Regulatory Flexibility Staring Contest: Will Industry Or FDA Blink First?

FDA may be able to talk in theoretical terms about the flexibility it is afforded for orphan products approvals, but others seem to want more tangible evidence. For its part, the agency wants more than general complaints about its regulations; it wants an open discussion of specific roadblocks.

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