FDA To Pilot AI-Based Animal Testing Alternatives For Drug Approvals

FDA hopes to accelerate pharmaceutical development and cut drug prices by advancing artificial intelligence and other alternatives to animal testing in drug development, beginning with a pilot program for monoclonal antibodies, the agency said Thursday (April 10). While the initial step is relatively modest, the commitment marks a major policy departure for FDA, where officials had previously said alternatives to animal testing weren’t advanced enough for a full transition. FDA Commissioner Marty Makary said in the statement, “This initiative marks...
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A Biden Health AI Regulation Unlikely To Survive Under Trump -- Can Industry Fill The Void?

A Biden-era regulation requiring health IT developers seeking federal certification for their products to disclose information about artificial intelligence algorithms to clinicians will likely be abolished or significantly narrowed under the Trump administration, a lobbyist, two lawyers and officials from three different trade groups told Inside Health Policy . The health AI regulation drawing stakeholder attention is the HTI-1 final rule’s 31 “source attribute” requirements for “predictive decision support interventions (PDSIs).” The ramifications of the expected regulatory shift could be...
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W&M Democrats See Political Motive In HHS Regional Office Closures

House Ways & Means Committee Democrats are demanding answers from HHS on the closure of regional offices, alleging the decision to shut down offices deliberately targeted areas that are predominantly home to Democratic voters. A Tuesday (April 8) letter led by W&M ranking Democrat Richard Neal (MA) calls on HHS Secretary Robert F. Kennedy Jr. to share details of his plans for the closure of five HHS regional offices, cutting the total number of regional offices in half. The offices...
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Trump OMB Issues Memos Promoting Federal AI Usage As FDA Cuts Experts

The Trump White House has posted anxiously awaited guidance updating policies on artificial intelligence usage and acquisition by HHS and other federal agencies, promoting widespread government adoption of AI -- with “strong safeguards” -- and spelling out revised rules for procurement of AI products and services. But as the Trump administration touts its support for AI, it has slashed key health AI experts in FDA offices that help manufacturers gain approval and bring new devices to patients. A health technology...
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Trump Adds New Criteria For Rolling Back HHS Rules

President Donald Trump’s latest regulation-cutting executive order directs HHS and other agencies to promptly scrap rules that could conflict with a slew of recent Supreme Court decisions -- a mandate that could lead to the removal of many existing health care rules and policies without an opportunity for public comment. In addition to an earlier order directing agencies to target regulations that might not hold up in court under Loper Bright Enterprises v. Raimondo -- which overruled the Chevron...
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House GOP Passes Senate-Amended Budget, Setting Stage For Medicaid Cuts In Reconciliation

The House narrowly passed the Senate-amended budget resolution Thursday (April 10) morning after a last-minute push by GOP leadership to win over a handful of conservative holdouts, clearing the way for a future reconciliation bill that’s expected to include deep cuts to the Medicaid program, which has been a major point of contention for congressional Democrats, advocates and some Republicans. Now that both chambers have officially agreed on a budget blueprint, House and Senate committees must begin drafting legislation to...
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Fourth Circuit Rules HHS Can Resume Probationary Worker Firings

A federal appeals court panel has cleared the way for HHS to begin removing from administrative leave thousands of workers who have continued to get paid after being laid off, although the Wednesday (April 9) order will likely be appealed to the full Fourth Circuit. Democratic attorneys general aiming to block the firing of probationary employees at agencies including HHS lack legal standing on the issue, according to the panel of judges on the Fourth Circuit Court of Appeals who...
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Trump Order Punishes Former CISA Official For Alleged COVID-19 Censorship

President Donald Trump has signed a memorandum revoking the security clearance of the first director of the Cybersecurity and Infrastructure Security Agency (CISA) over allegations he worked with social media companies to suppress conservative viewpoints on COVID-19 under the guise of combatting purported misinformation. That’s despite the Supreme Court finding there was no evidence of a coordinated government push for platforms to suppress the content. Trump also ordered a review of the former director Chris Krebs’ activities at the agency...
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AdvaMed Applauds Reciprocal Tariff Pause; Dems, Med Tech Groups Had Raised Alarms

The medical device lobby is applauding President Donald Trump’s decision to pause the administration’s reciprocal tariffs, after multiple lobby groups and Democratic lawmakers had raised alarms the now-stalled tariffs would cripple the medical supply chain. But large tariffs remain on China. Advanced Medical Technology Association CEO Scott Whitaker says the group is encouraged by the pause, calling it “an important decision that restores some short-term certainty to global markets, including the American medtech industry, which is number one globally.” “Moving...
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FDA Issue: 
FDA Week - 04/11/2025
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Vol. 31, No. 15
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E&C Punts SUPPORT Act Vote, GOP Rejects Dem’s December Deal Revival

The House Energy & Commerce Committee adjourned its markup Tuesday (April 8) without voting on legislation to reauthorize the landmark law to address the opioid crisis, the SUPPORT Act, and committee Republicans rejected a proposal from Democrats to advance most portions of the bipartisan, bicameral health deal that stalled in December after Elon Musk nixed the broader spending bill it was part of. “It’s clear Republicans are more interested in aligning with billionaires and Elon Musk than standing up for...
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CMS Issue: 
Inside CMS - 04/17/2025
CMS Volume: 
Vol. 28, No. 16

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