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insider.thefdagroup.comLatest Issues
Embedding a Clinical QA Consultant for Phase 3 QMS Development
Most small pre-commercial sponsors don’t have the luxury of spending much time thinking about what happens if their drug actually makes it out of Phase 1 and 2 trials.
Most of the time, these teams are small, the budgets are tight, and the...
5 Things We Commonly Find in SOP Gap Analyses
Specific findings differ from one procedure to another, but a few overarching gaps tend to be the same.
We’ve run SOP gap analyses across a wide range of organizations: device manufacturers, pharma sponsors, CROs, and clinical sites.
The FDA's One-Day Inspection Pilot Is Already Running
FDA Commissioner Marty Makary announced a new inspection pilot yesterday morning at the Food and Drug Law Institute Annual Conference in Washington. The FDA also made an official announcement on its website.
The agency has been conducting...
Guidance Breakdown: FDA Formalizes CMC Flexibilities for Cell and Gene Therapy Products Heading Toward BLA
A quick breakdown of CBER's final guidance on CMC flexibilities for human CGT product development.
This guidance breakdown is available in full to paid subscribers. Only paid subscribers get regular full access to our guidance breakdowns a...
How Contracted Insourcing is Making Clinical Operations More Efficient
Many sponsors we talk to still think about resourcing their ClinOps functions in one of two ways: Either open a full-time req and wait, or outsource the work. But we've seen more teams moving away from that binary, and the companies getting...
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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates.
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