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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog: Drug Discovery

Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). FDAs withdrawal authority when a confirmatory trial is not conducted with due diligence was expanded to include that FDA could specify the conditions for a postapproval study.

FDA 105
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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

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AI-Designed Enzymes

Codon

Traditionally, scientists discover enzymes in nature and adapt them through trial and error. He also writes on a blog focused on the intersection of biology and AI at owlposting.com. These molecular machines power various cellular processes, from converting sugar into energy to switching genes on and off.

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Déjà Vu: OPDP Again Targets Provider Branded Website of Accelerated Approval Drug in Second Untitled Letter of 2025

FDA Law Blog: Biosimilars

The Untitled Letter notes that the confirmatory trial for LYTGOBI is currently ongoing and has not been completed; therefore, clinical benefit of LYTGOBI has not yet been confirmed. As a single-arm trial (i.e., The Untitled Letter states that a randomized controlled trial would be needed to assess delay in time to disease progression.

Drugs 52
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How EDC-Based SAE Reporting Reduces Time to Detection and Response in Clinical Trials

Crucial Data Solutions

Serious adverse events (SAEs) are among the most critical data points collected during a clinical trial. The post How EDC-Based SAE Reporting Reduces Time to Detection and Response in Clinical Trials appeared first on Crucial Data Solutions. The timeliness and accuracy.

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Time for change: non-human primates in drug research

Drug Target Review

Their unique suitability has made them valuable for evaluating pharmacokinetics, toxicology and safety in drug candidates before human clinical trials. NHP-C cardiomyocytes offer a more predictive and ethical platform, especially for drugs intended to advance from animal testing to first-in-human trials. Toxicology Research.

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Altasciences At CPHI Americas 2025

Alta Sciences

Attendees were particularly drawn to our integrated solutions, which encompass everything from lead candidates advancing to IND-enabling programs to early-phase clinical trials to full-scale commercial manufacturing. This blog was originally published in July 2025. Image Thumbnail_Blog_Lisa-v2.jpg