Unlicensed Stem Cell Clinics Are 'Surrogate' For Right To Try, US FDA's Marks Says
CBER director said unlicensed stem cell clinics often report adverse events not made public, which is a concern under Right To Try.
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Academic institutions confused about agency standards are overly cautious in requiring early-phase studies be conducted under full GMPs, experts say; CBER Director Marks highlights regulatory flexibility but cautions that formal written guidance could be misused by those in stem cell industry.
Gottlieb: Lack Of Compromise On Right-To-Try Bill Is 'Interesting Lesson In Politics' For Stakeholders
In interview with the Pink Sheet, former US FDA commissioner Scott Gottlieb said that opposition to the modified House version of the right-to-try legislation ultimately led to the less favorable Senate bill becoming law.
OPDP's first 2019 letter cites problematic claims about an investigational PET drug; investigator's response was to adjust verb tenses and other wording in the blog post.