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Approve Suite Weekly · Friday, September 25, 2026 · read online
8-K: Glucotrack, Inc. mentions clinical hold
Glucotrack reports FDA clinical hold on company clinical investigation. A clinical hold suspends all patient enrollment and dosing in the affected trial(s), halting clinical development. This is a critical regulatory action requiring FDA communication and a remedial plan before studies can resume. Lion Street Medical cited for MDR violations and misbranding of negative pressure wound therapy systems. The firm failed to establish and maintain Medical Device Reporting procedures required by regulation, a critical post-market safety obligation. This warning letter signals deficiencies in the firm's ability to detect, evaluate, and report adverse events associated with their wound therapy devices. The pattern? Trial status changes led the week with 35, ahead of CFR amendments (21), out of 103 counted.
This week's author: Ryan Burke, Approve Suite
8-K: Glucotrack, Inc. mentions clinical hold
8-K · Glucotrack
Glucotrack reports FDA clinical hold on company clinical investigation.
Why it matters. A clinical hold suspends all patient enrollment and dosing in the affected trial(s), halting clinical development. This is a critical regulatory action requiring FDA communication and a remedial plan before studies can resume.
What to watch. Items 1.01, 2.02 and 8.01 carry the material terms; the exhibits hold the detail.
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Warning letter: Lion Street Medical, d/b/a Pensar Medical LLC — Medical Device Reporting/Misbranded
Warning letter · Lion Street Medical, d/b/a Pensar Medical LLC
Lion Street Medical cited for MDR violations and misbranding of negative pressure wound therapy systems.
Why it matters. The firm failed to establish and maintain Medical Device Reporting procedures required by regulation, a critical post-market safety obligation. This warning letter signals deficiencies in the firm's ability to detect, evaluate, and report adverse events associated with their wound therapy devices.
What to watch. The firm's written response is due in 15 working days; FDA posts a close-out letter only after it verifies the corrections.
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Nonclinical Testing Terminology
Final rule
FDA finalizes nonclinical testing terminology amendments across IND, NDA, and biologics regulations.
Why it matters. The rule substitutes 'nonclinical' for 'animal' and 'preclinical' throughout 21 CFR 312, 314, 315, and 601, aligning terminology with recent legislative amendments. This removes emphasis on animal testing as the sole methodology and signals FDA openness to alternative testing approaches, potentially accelerating development of new safety assessment methods.
What to watch. The amended text appears in the eCFR on the effective date; procedures that cite the section are the ones affected.
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By the numbers
Inspections: 0 NAI · 0 VAI · 0 OAI Warning letters: 17 Class I recalls: 0 (Class II 0, Class III 0) Trial stops and status changes: 35 (results posted: 12) Raises: 8, $187M disclosed
329 events, down 23% on the prior 7 days.
180 listed companies report under 12 months of runway.
Signals
1. 8-K: Alaunos Therapeutics, Inc. mentions clinical hold 8-K · Alaunos Therapeutics app 2. Warning letter: kdc/one Chatsworth, Inc. — CGMP/Finished Pharmaceuticals/Adulterated Warning letter · kdc/one Chatsworth, Inc. app 3. Warning letter: NexCell Scientific Inc — Unapproved New Drugs/Unlicensed Biological Product Violations Warning letter · NexCell Scientific Inc app 4. 8-K: Aquestive Therapeutics, Inc. mentions complete response letter 8-K · Aquestive Therapeutics app 5. NCT05861050: Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma — Now SUSPENDED Phase 1/2 · National Cancer Institute (NCI) app 6. 21 CFR §312.82 amended — Early consultation. Part 312 app
Why this exists
Approve Suite Weekly exists so a QA or RA lead can read one email on Monday and know what FDA, the SEC and ClinicalTrials.gov published last week. Every line links to its public source; nothing here is advice.
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