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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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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

They also present a more intense focus on the timelines for confirmatory study initiation and completion as well as the feasibility of those studies to verify clinical benefit within those timelines. However, the meaning of due diligence has long been a question. rare disease settings).

IT 105
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Digital Skin Care: Top 8 Dermatology Apps

The Medical Futurist

SkinIO , Scanoma , Miiskin , FirstDerm , Direct Derm , iDoc24 , and SkinVision all work based on the same principle: they promise patients the option to self-check their symptoms and then to connect to a dermatologist online for consultation within a very short period of time.

Patients 111
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RCT of Default Inpatient PC Consults: Kate Courtright & Scott Halpern

GeriPal

This week, we talk about the other major palliative care trial of default palliative care consults for hospitalized older adults with COPD, kidney disease, or dementia, published in the same issue of JAMA. and consulting for Papa Health. So in this case consultations. Scott: Kate would miss you. laughter] Alex: Yeah.

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When to Go to Urgent Care for a Sore Throat: How Can Urgent Care Help?

Doctor On Demand

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. In fact, most sore throat symptoms resolve in three days for 60-70% of patients, according to March 2025 UpToDate, an evidence-based clinical decision support system used by healthcare professionals. Is my sore throat contagious?

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Medical Cannabis Revisted: A Podcast with David Casarett and Eloise Theisen

GeriPal

This is back in, I don’t know, like 2014 maybe. And then I met a patient in clinic once who asked me a lot of really intelligent questions about medical cannabis, what it does. I’d been a nurse at the time, and I went back to do my clinicals in an oncology clinic locally. Eric, do you want me to go first?

Medical 98
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Sweet! A Metabolic Disorders focused podcast episode

PEMBlog

She is a member of the Clinical Genome Resource Inborn Errors of Metabolism (IEM) Clinical Domain Working Group, where as a biocurator she assesses the pathogenicity of variants in IEM-associated genes to facilitate expedited genetic diagnosis for IEMs. On clinical presentation. Available from: [link] Rice GM, Steiner RD.