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Guidance Breakdown: FDA Proposes eSTAR for IDEs
CDRH and CBER issue their first draft guidance on electronic submission templates for Investigational Device Exemption applications.
3 hrs ago
•
The FDA Group
15
1
Pharma Tech Transfer Is Knowledge Transfer, with Paige Kane, PhD, CPIP
CAI’s Paige Kane on why the “know-why” rarely makes it into the documents, and the structured questions that bring it to the surface.
Oct 26
•
The FDA Group
8
1
17:58
Pharma Tech Transfer Is Knowledge Transfer
Why does tech transfer remain so hard in pharma , even when every document is neatly in order?
Oct 26
•
The FDA Group
17:58
Guidance Breakdown: FDA Revises Its Small Entity Guide on IND and BA/BE Safety Reporting
The October 2026 revision adds no new requirements. What it does is confirm which guidances are current, and that two guidances your safety SOPs may…
Oct 23
•
The FDA Group
15
1
The AICA Pricing Explainer: A Quick Walkthrough of How It Works
How AICA’s usage-based pricing works, which plan fits which team, and how to get started.
Oct 21
•
The FDA Group
4
4:11
Consultant Spotlight: Jeff Jackowski on Remediation Work That Lasts
We chat with one of our consultants on his three years in Istanbul, life under a consent decree, and why the site team has to own the corrective action.
Oct 21
•
The FDA Group
6
17:02
The Adoption Assumptions Hiding in Your Regulatory Strategy, with Holley Miller
A 30-year medtech marketer on the adoption assumptions hiding inside every regulatory pathway decision, and why “better” so rarely wins.
Oct 20
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The FDA Group
8
1
1:03:37
The Adoption Assumptions Hiding in Your Regulatory Strategy
Can the fastest path to FDA approval end up being the slowest path to market adoption?
Oct 20
•
The FDA Group
1:03:37
RA/QA News Roll: Mid October 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Oct 16
•
The FDA Group
7
1
FDA Rewrites Its Container Closure Expectations, a Dialysis Concentrate Warning Letter + an Eye Drop Maker's Repeat Sterility Failures
A draft guidance would replace FDA's container closure framework, a dialysate concentrate maker is cited for failed endotoxin testing, and an eye drop…
Oct 9
•
The FDA Group
15
1
41:49
RA/QA News Roll: Late September 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
Oct 7
•
The FDA Group
7
1
Dr. Robert Califf on What It Will Take for GLP-1s to Become a Public Health Success
The two-time FDA Commissioner on treating a patient versus improving a population's health, why access to these drugs has followed resources, and why he…
Oct 5
•
The FDA Group
9
1
33:22
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