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Latest From Review Pathway
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.
House opioid package includes ability to deny or withdraw products because of abuse potential, but new Senate package does not, setting up potential conference battle.
China is overtaking the US as the largest cell development market, with over 2,300 registered clinical trials.
Initiatives to promote information sharing and reliance among developing country regulators are bearing fruit in the Caribbean and Africa, although much works remains to be done, according to speakers at last week’s pre-ICDRA conference in Dublin.
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