|OpGen Supports Passage of Landmark 21st Century Cures Act to Expedite Development of Solutions for Bacterial Infections|
“The passage of this historic legislation provides important improvements in the regulatory framework for drugs, diagnostics, and information products to combat the rise of antibiotic resistant infections. The 21st Century Cures Act creates a new approval pathway for antibacterial and antifungal drugs intended to treat serious life threatening infections in limited populations of patients for which there is an unmet medical need. Infections with many of the most drug resistant pathogens potentially fall within this category of patients.
The Act makes improvements in the regulation of medical and decision support software, and for identifying and updating antibiotic susceptibility test interpretive criteria. We believe these improvements will help manufacturers respond more quickly to the rising global threat of antibiotic resistance. The Act also creates requirements for resources to address education, development, and implementation of antibiotic stewardship programs.”
“On a broader scale, this legislation provides