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GAIN Begins (Part 1): FDA Completes Turnaround On Antibiotic R&D

 
• By Kate Rawson

In less than two years, FDA has moved from requiring unrealistic approval standards for antibiotics to exploring innovative ways to shorten the pathway for the most-needed drugs. And, surprise: Congress is on board too. After 15 years, there is finally real momentum on antibiotic drug policy. But is it all enough to get companies back in the game?

The Food & Drug Administration is working to encourage one area of drug development more than any other. Is it oncology? No. Obesity and diabetes? No. Pediatric rare diseases? No. Alzheimer’s disease and dementia? No.

Antibioti

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