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Here's what's happening at FDA and across the broader life science RA/QA space.
The FDA Group
[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).
The FDA Group
[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min) | We explore FDA's new list of alternative ways to comply with cGMP requirements for combo products, dissect a new draft guidance for…
The FDA Group

February 2023

Wondering which GMP-related CFRs FDA is citing most frequently? Check out our interactive data visualizations and prioritize your compliance assurance…
The FDA Group
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min) | We explore FDA's new list of alternative ways to comply with cGMP requirements for combo products, dissect a new draft guidance for…
The FDA Group

January 2023

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…
The FDA Group
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min) | We explore FDA's new list of alternative ways to comply with cGMP requirements for combo products, dissect a new draft guidance for…
The FDA Group

December 2022

Access every white paper and webinar we've ever produced — a library of life science insights you won't find elsewhere.
The FDA Group
Reporting CMC Post-Approval Changes, Proactively Addressing the Root Causes of Medical Device Recalls + Warning Letter BreakdownWatch now (46 min) | We explore a new guidance clarifying post-approval changes to disposable materials, examine new research into the root causes of…
The FDA Group

November 2022

Reviewing RMPs Against FDA's Drug Shortage Guidance, Inside FDA's Device VIP + Warning Letter BreakdownWatch now (32 min) | We distill the key points from FDA's RMP-impacting drug shortage mitigation guidance, explore FDA's device voluntary improvement…
The FDA Group

October 2022

Revisions to Q9(R1) Quality Risk Management, Getting "Recall Ready" + Warning Letter Breakdown Watch now (26 min) | We look at the recent Q9(R1) Quality Risk Management revisions, highlight key takeaways from FDA's finalized recall readiness…
The FDA Group
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