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Here's what's happening at FDA and across the broader life science RA/QA space.
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[Bonus Issue] Inside FDA's Pre-Approval Inspections with Former FDA Investigator, Christopher SmithWatch now (51 min) | Former FDA Investigator, Christopher Smith shares his insights on FDA Pre-Approval Inspections (PAIs).
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[March 2023 Issue] Implementing ICH Q14’s Enhanced Approach to Analytical Method Development, FDA's Proposed Framework for Human Factor Info…Watch now (46 min) | We explore FDA's new list of alternative ways to comply with cGMP requirements for combo products, dissect a new draft guidance for…
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Wondering which GMP-related CFRs FDA is citing most frequently? Check out our interactive data visualizations and prioritize your compliance assurance…
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Revised Compliance Guides for PAIs and GMP Drug Inspections, New Guidances On Device Post-Approval Studies, Postmarket Surveillance …Watch now (46 min) | We explore FDA's new list of alternative ways to comply with cGMP requirements for combo products, dissect a new draft guidance for…
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Have RA/QA/Clinical questions you'd like our experts to address in a future issue? Paid subscribers can submit questions at any time using our simple…
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The new omnibus package includes a number of changes that expand FDA’s inspection authorities and reform the way FDA conducts inspections.
The FDA Group
Alternative cGMP Compliance Methods for Combo Products, Device Production and Quality System Software Assurance + Warning Letter BreakdownWatch now (46 min) | We explore FDA's new list of alternative ways to comply with cGMP requirements for combo products, dissect a new draft guidance for…
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