Gottlieb Floats New Antibiotic Payment Model In LPAD Announcement
US FDA Commissioner outlines licensing fee reimbursement arrangement intended to provide better financial incentives for development.
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US FDA and CMS explore reimbursement ideas to strengthen business case for antimicrobial development; new approval pathway likely is only needed in special situations.
Non-Traditional Antimicrobials Can Follow Regulatory Path Laid By Small Molecule Antibiotics, US FDA Says
Live biotherapeutics, fecal microbiota transplants and bacteriophages may be novel when it comes to fighting hard-to-treat infections, but their development and route to approval may not be all that different than traditional antibiotics, officials from FDA’s drugs and biologics center say.
The Swiss major says that while the science for its antibacterial and antiviral research programs is compelling, "we have decided to prioritize our resources in other areas where we believe we are better positioned to develop innovative medicines."