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[May 2023: The Compliance Issue] Addressing the Top-Cited CFRs to Pharma and Device Firms + Warning Letter Breakdown
Watch now (47 min) | We take a close look at most frequently cited CFRs to drug and device firms throughout FY2022 and break down two recently issued…
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Introducing our Functional Service Program (FSP)
Watch now (2 min) | Bundle your RA/QA projects with The FDA Group for deep discounts.
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[April 2023 Issue] FDA Finalizes Guidance on REMS Format and Content, Preparing for Expanded Device Inspection Authority + Warning Letter…
Watch now (50 min) | We explore FDA's expectations for the format and content of a REMS, how to prepare for more medical device inspection authority…
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The FDA Group
RA/QA News Roll: March 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
[Bonus Issue] Inside FDA's Pre-Approval Inspections with Former FDA Investigator, Christopher Smith
Watch now (51 min) | Former FDA Investigator, Christopher Smith shares his insights on FDA Pre-Approval Inspections (PAIs).
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The FDA Group
Implementing ICH Q14’s Enhanced Approach to Analytical Method Development, FDA's Proposed Framework for Human Factor Info in Device…
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min) | We explore FDA's new list of alternative ways to comply with cGMP requirements for combo products, dissect a new draft guidance for…
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The FDA Group
[Bonus Issue] Top 5-Year Trending FDA GMP Inspection Citations (FY2018 to FY2022)
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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The FDA Group
The FDA Group's Insider Newsletter
The FDA Group's Insider Newsletter
The latest news and exclusive analysis across the FDA-regulated industries from former FDA professionals and industry experts. New issues every month. Save time gathering the critical industry intelligence you need to act on.
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