BARDA Official Worries About How Non-Traditional Antibiotics Will Get To Market
Promising non-traditional antibiotic therapies need a clear path to market to entice investment, US Biomedical Advanced Research and Development Authority official says.
You may also be interested in...
The FY 2018 PDUFA performance report also indicates that applications with standard assessments fell compared to long-term averages.
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.