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Guidance Breakdown: Providing Regulatory Submissions in Electronic Format — IND Safety Reports
 • The FDA Group
FDA Guidance Breakdown: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
 • The FDA Group
One of the Most Concerning Warning Letters We've Seen in a While
 • The FDA Group
[January 2024 Issue] FDA Issues New Guidance on RIEs, Premarket Cybersecurity Considerations for Device Quality Systems + Warning Letter…
 • The FDA Group
Guidance Breakdown: The FDA Updates its GUDID Final Guidance
The update makes minor revisions from the previous 2014 guidance, including the removal of now-unneeded FDA Preferred Terms or codes from the database…
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The FDA Group
RA/QA News Roll: Late December 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
[December 2024] Nitrosamine Control, Device Remanufacturing + Warning Letter Analysis
Watch now (17 mins) | This month we examine the FDA's evolving stance on pharmaceutical impurity controls and device remanufacturing requirements, while…
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The FDA Group
16:41
RA/QA News Roll: Mid December 2024 ❄️
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
Are You Ready for Your Next Data Integrity Audit?
Here's what our auditors look for and how to assess your own readiness heading into 2025.
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The FDA Group
Inside the FDA Warning Letter Over the Study of a Rejected Rare Disease Drug
Following the FDA’s rejection of Applied Therapeutics’ experimental drug for classic galactosemia, the company announced that it also received a warning…
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The FDA Group
Guidance Breakdown: FDA's BIMO Electronic Submission Requirements
The FDA just released its final guidance finalizing draft requirements from 2018 into binding requirements for electronic submission of clinical study…
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The FDA Group
Guidance Breakdown: FDA Sets New Expedited Withdrawal Procedures for Accelerated Approvals
The FDA just released new details on how it plans to expedite the withdrawal of certain accelerated approvals when drugs fail to show clinical benefit…
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The FDA Group
Guidance Breakdown: PCCPs for AI-Enabled Device Software Functions
The FDA's long-awaited final guidance maps out how AI/ML devices can evolve post-market. We break down the new PCCP guidance.
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The FDA Group
RA/QA News Roll: Late November 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
One of the Most Concerning Warning Letters We've Seen in a While
Deleted, destroyed, and deliberately hidden: inside an FDA warning letter that reveals systematic data fraud.
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The FDA Group
45:29
[November 2024] The Patient Safety & Risk Management Issue: Clinical Trial Diversity, Use-Related Risk Analysis + Warning Letter Breakdown
This month we examine new FDA mandates reshaping clinical trial diversity and product risk management, while a warning letter breakdown reveals crucial…
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The FDA Group
38:24
The Smart Way to Adopt AI in Clinical Trials and Regulatory Affairs with Keith Parent
A look at the practical applications and implementation strategies for AI in clinical trials and regulatory spaces with Keith Parent, CEO of Court…
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The FDA Group

RA/QA News Rolls

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RA/QA News Roll: Late December 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
 • 
The FDA Group
RA/QA News Roll: Mid December 2024 ❄️
Here's what's happening at FDA and across the broader life science RA/QA space.
 • 
The FDA Group
RA/QA News Roll: Late November 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
 • 
The FDA Group
RA/QA News Roll: Mid November 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
 • 
The FDA Group
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