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.
You may also be interested in...
Amikacin liposome inhalation suspension for the treatment of Mycobacterium avium complex lung disease is first antimicrobial approved under 21st Century Cures Act pathway; LPAD designation request appears to have occurred after an advisory committee recommended approval for more limited population than requested by Insmed.
Microbiome, Clinical Trial Enrichment Among Question Marks As US FDA Weighs Guidance On Non-Traditional Infectious Disease Treatment
Discussions among panelists at US FDA meeting reveal lack of consensus in many key areas.
Commissioner Scott Gottlieb notes consideration of the pull incentive shortly after REVAMP Act stalls in the House.