The “Generating Antibiotic Incentives Now (GAIN) Act provides incentives
for pharmaceutical companies to develop new antibiotics/antibacterial
drugs for the treatment of life-threatening infections caused by multi-drug
resistant bacteria, such as methicillin-resistant Staphylococcus
aureus (MRSA), vancomycin-resistant Staphylococcus and enterococcus,
Acinetobacter, Klebsiella, Pseudomonas, E. coli, multi-drug resistant
Tuberculosis, and Clostridium difficile. Under the GAIN Act Qualified
Infectious Disease Products (“QIDPs”) intended to treat serious or life-threatening
bacterial infections may benefit from the following incentives:
- 5 Years additional US Market Exclusivity
- Priority FDA Review reducing from 12 to 8 months
- Fast Track Status
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