Antibiotics Pathway Legislation Gets Continued Push Despite FDA Moves
This article was originally published in The Pink Sheet Daily
Executive Summary
Twenty organizations sign letter to House and Senate members indicating creation of a limited-population antibiotic drug pathway still is necessary and FDASIA incentives are only a start.
You may also be interested in...
Recipe For Doubling Innovative Medicines Includes New Approval Pathway, FDA Management Changes
Presidential advisory panel makes eight recommendations to improve innovation in drug discovery, development and evaluation; calls for broad partnership of stakeholders to accelerate therapeutics, $40 million annual appropriations for FDA’s Sentinel System.
With GAIN In Place, Antibiotic Improvements Depend On FDA Implementation
FDA and industry are turning their attention to implementation of the Generating Antibiotic Incentives Now provisions of PDUFA V, which include an additional five years of marketing exclusivity for certain products and new guidance aimed at streamlining the drug development process.
Rare Cancer Development Consortium Moving Toward Target Selection
An upcoming public meeting will include a look at platforms before the first targets are chosen.