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4 Ways Quality Teams Are Augmenting Themselves With Full-Time Consultants
A quick look at some of the recent ways we’ve placed full-time consultants inside client Quality organizations over the past few months, and what those…
Sep 25
•
The FDA Group
5
1
Draft Guidance Breakdown: FDA Proposes Making eSTAR Mandatory for Certain PMA Submission Types
A breakdown of the draft guidance on the electronic submission template for PMAs, including the technical screening process that would replace RTA…
Sep 24
•
The FDA Group
10
RA/QA News Roll: Mid September 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Sep 23
•
The FDA Group
4
Is Your Biotech De-Risking or Just Delaying?
Baseimmune's CEO Kevin Walton on beachhead decisions, why accumulating supportive data can be a form of procrastination, and what’s actually getting…
Sep 18
•
The FDA Group
6
1
34:57
Is Your Biotech De-Risking or Just Delaying?
What stops a promising platform from becoming an investable company?
Sep 18
•
The FDA Group
34:57
The FDA's Expedited IND Pilot Is Live
The agency published the final design and opened applications. Eight to ten sponsor-institution pairs will be selected.
Sep 15
•
The FDA Group
6
2
1
A Few Best Practices for Scheduling GxP Audits
We talked to our account managers and auditors to surface the things the people who build these schedules and go to these sites wish more teams did.
Sep 15
•
The FDA Group
6
1
Reg Ops Has Been Kept in a Box. This Is the Way Out, with Carla Griffin
Why FDA's real-time clinical trials work is an opportunity for regulatory operations professionals rather than a threat, and what to do in the next…
Sep 14
•
The FDA Group
7
1
24:00
Reg Ops Has Been Kept in a Box. This Is the Way Out.
As the FDA takes its first steps toward receiving clinical data in real time, what happens to regulatory operations professionals?
Sep 14
•
The FDA Group
1
24:00
[August 2026] FDA's New Rulebook for Formal Meetings, Human Factors Harmonized with QMSR + A Warning Letter Under the New Device Rule
The FDA rewrites how sponsors request meetings during drug development, folds human factors into the quality system, and posts a warning letter written…
Sep 11
•
The FDA Group
8
1
41:40
RA/QA News Roll: Late August 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Sep 10
•
The FDA Group
4
1
The FDA Just Signaled It Will Throw Out Foreign Trial Data It Can’t Verify
Four center directors signed a joint statement on GCP and foreign clinical data. No new requirements, but it’s important for how you select sites.
Sep 4
•
The FDA Group
10
1
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