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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

However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.

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FDA Approves Clinical Trials for Pig Kidney Transplants in Humans

Drugs.com

Food and Drug Administration (FDA) has approved the first-ever clinical trials testing pig kidney transplants in people with kidney failure, marking a major step forward in cross-species transplantation.Two. TUESDAY, Feb. 4, 2025 -- The U.S.

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FDA Guidance on Advancement of Decentralized Clinical Trials

ProRelix Research

Although the United States Food and Drug Administration (FDA) has always supported and advocated the idea of decentralized trials, the real adoption and application of decentralized aspects in trials has […] The post FDA Guidance on Advancement of Decentralized Clinical Trials appeared first on ProRelix Research.

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FDA lifts hold on PTC Huntington’s disease trial

BioPharma Drive: Drug Pricing

The agency has lifted a partial trial suspension based on one-year data showing PTC’s pill suppressed a key protein associated with the disorder.

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FDA puts Novavax flu vaccine trials on hold

BioPharma Drive: Drug Pricing

The hold, which was made in response to a serious adverse event report, could impact the company’s plans to start a Phase 3 trial of a combination shot for COVID-19 and influenza.

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Why Including Patients in FDA Engagement Will Benefit Your Trial

Conversations in Drug Development Trends

Patients are the backbone of clinical trials, playing an essential role in the drug development process. However, patients also play a vital role in engaging directly with the FDA. Her fellow panelists represented a diverse group of stakeholders across clinical research, including patient advocates, sponsors, sites, and the FDA itself.

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Clinical trial phases: What’s the difference?

Antidote

Clinical trials are how researchers advance their knowledge about potential new treatments, including medications, medical devices, and lifestyle interventions. Clinical trials are divided into phases , each with a distinct duration, purpose, and number of volunteers needed.