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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
1
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
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The FDA Group
10
1
Trump Nominates Heidi Overton for FDA Commissioner
What we know so far, and what it may signal about the agency's direction.
Aug 19
•
The FDA Group
4
1
House Appropriators Tell FDA to Accelerate its IND Sign-Off
Congress wants faster entry into early-phase trials as drug development keeps shifting toward China and Australia.
Jun 11
•
The FDA Group
7
1
A Quick Explainer on the FDA's Leadership Shakeups
There's been a lot happening. Here's a simple guide for catching up with recent personnel changes.
May 20
•
The FDA Group
5
1
The FDA's One-Day Inspection Pilot Is Already Running
What we know about the new "inspectional assessments."
May 7
•
The FDA Group
3
1
More OMQ Letters After FDA Inspections? Don't Treat Them as Noise
We're hearing that manufacturers are getting more post-inspection mail from CDER. Here's what the letters actually mean for your next inspection.
May 4
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The FDA Group
5
2
10 Takeaways from FDA's QMSR Town Hall on Risk-Based Inspections
A quick breakdown of FDA's April town hall on risk-based medical device inspections under the new Compliance Program 7382.850.
Apr 28
•
The FDA Group
15
1
An FDA Warning Letter Came With Pictures
A picture really is worth a thousand words (or in this case, a thousand lines of dense warning letter text).
Mar 24
•
The FDA Group
8
2
What’s Been Happening at the FDA Lately: A Roundup
The past several weeks have been among the most eventful (and chaotic) in recent FDA history. Here's what's been happening.
Mar 18
•
The FDA Group
4
1
A Quick Explainer on FDA's Consolidated Adverse Events Reporting System
The new Adverse Event Monitoring System (AEMS) consolidates decades of fragmented safety reporting. If your company submits adverse event reports to the…
Mar 17
•
The FDA Group
3
1
Industry Pushes for Automatic Post-Inspection Meetings and Faster FDA Response Times
What the January CMC subgroup discussions reveal about potential changes to the Form 483 process amid PDUFA VIII negotiations.
Feb 9
•
The FDA Group
4
1
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