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Innovative Product Approval Showcase: A Quick Mid-Year Roundup
From precision oncology breakthroughs to patient-driven diagnostics, here are some of the FDA’s most impactful approvals of 2025 so far.
Aug 8
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The FDA Group
The FDA Announces PreCheck: A Fast-Track for Building U.S. Drug Plants
A new two-phase “PreCheck” pathway could shave months off U.S. plant construction while turning early regulatory engagement into a competitive edge for…
Aug 7
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The FDA Group
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Streamlining Drug Safety: A Look at FDA's New Framework for Smarter Clinical Trial Data Collection
The CDER just published a new white paper on Selective Safety Data Collection. We dissect it.
Jul 24
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The FDA Group
2
Trump Gives Medical Device Sterilizers Two More Years to Comply with EtO Limits
President Donald Trump issued an executive order granting a two-year extension for medical device sterilization facilities to comply with the new limits…
Jul 23
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The FDA Group
2
FDA Publishes 200+ Complete Response Letters in Historic Transparency Shift
The letters published on Thursday were issued in response to applications the FDA had received between 2020 and 2024. It said it's in the process of…
Jul 11
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The FDA Group
4
FDA Launches Priority Voucher Program to Accelerate Critical Drug Reviews
The FDA announced its Commissioner’s National Priority Voucher (CNPV) program, allowing drug developers to shorten FDA review time from 10–12 months to…
Jun 19
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The FDA Group
6
A Few Thoughts on How FDA's AI-Powered Risk Targeting with Elsa Could Change Inspection Readiness
The FDA says its new AI tool, Elsa, can now help pinpoint inspection targets faster and more precisely—here’s what firms might want to start thinking…
Jun 9
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The FDA Group
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FDA Launches Its AI Tool 'Elsa' Ahead of Schedule to Enhance Agency Operations
The FDA says its new large language model–powered tool is already accelerating reviews, aiding inspections, and supporting database development as part…
Jun 4
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The FDA Group
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Are Workforce Cuts Slowing Down the FDA? Here's What Our Consultants Are Seeing
Anecdotes from the field reveal a complex, uneven picture of how FDA’s internal upheaval is playing out in practice at the moment.
May 29
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The FDA Group
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Our 7 Takeaways from the New MAHA Report
The White House published its MAHA commission report, outlining key priorities of the Trump administration for transforming the US healthcare system and…
May 22
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The FDA Group
5
The FDA Plans to Roll Out AI for Reviews This Summer — Here's What to Know
The agency just set an "aggressive timeline" for AI Implementation after a successful pilot. Here's what to start thinking about now.
May 14
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The FDA Group
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Tracking Major Changes at the FDA: May 13
Policy shifts, AI rollouts, reappointments, and legal backlash.
May 13
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The FDA Group
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