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A Quick Look at the Evolving Legal and Legislative Situation Surrounding the FDA's LDT Final Rule
Regulatory attorney Christine P. Bump gave an informative breakdown of the implications of recent judicial and legislative activity potentially…
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The FDA Group
Introducing The Passionate Workforce Podcast: How to Drive Excellence Across Teams with Jennifer Mascioli-Tudor
Nick Capman launches a new podcast to explore the key strategies and insights needed to build a passionate and engaged workforce.
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The FDA Group
55:14
Applying AI in the Life Sciences with MasterControl's Matt Lowe
We sat down with Matt Lowe, Chief Strategy Officer at MasterControl, to explore the promising applications — and potential pitfalls — of AI in the life…
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The FDA Group
30:35
RA/QA News Roll: Mid July 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
[July 2024] FDA to Use More Remote Assessments for Low-Risk Facilities, a New Q-sub Draft Guidance + Warning Letter Breakdown
Watch now (24 mins) | We explore what it means to be "remote assessment ready," discuss proposed changes to the Q-sub program, and dissect a warning…
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The FDA Group
23:29
FDA's CBER Revises its SOPP for Processing and Reviewing INDs: What Sponsors Need to Know
A quick breakdown of CBER's recent SOPP revisions for incoming INDs.
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The FDA Group
Guidance Breakdown: Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products
The FDA outlines a comprehensive approach to identifying and mitigating use-related risks for drugs, biologics, and combo products throughout product…
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The FDA Group
Navigating Challenges in Raw Material and Finished Product Storage with Eric Busenburg
We sat down with Eric Busenburg, President of Euro-American Worldwide Logistics, to unpack the storage challenges facing life science manufacturers and…
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The FDA Group
32:55
What the Overturning of Chevron Could Mean for the FDA and Industry: A Roundup of Initial Analyses
Legal experts and industry analysts weigh in on how the end of Chevron could reshape FDA regulations and the life sciences.
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The FDA Group
Using Full-Time Consultants to Build a Quality Department: A Staff Augmentation Success Story
How a mid-size biopharma consultants to set up and build a quality department — and tackle projects across its subsidiaries.
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The FDA Group
RA/QA News Roll: Late June 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group

June 2024

Guidance Breakdown: Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
The FDA defines the types of behaviors it considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry.
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The FDA Group
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