FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. However, the 2014 Guidance cannot be ignored entirely. By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J.

Clinic 64

Clinic Relationship Provider IT 64

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

Manufacturing 81

Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

FEBRUARY 29, 2024

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit.

Clinic 59

Clinic IT Provider Patient-Centered 59

Doctor On Demand

APRIL 28, 2025

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. This requires emergency treatment.

ER 52

ER Telehealth Primary Care Doctor Appointment 52

The Clinical Problem Solvers

MARCH 4, 2024

42:00 Abolitionist reimaginings of Health 55:05 Democratizing Narrative Medicine 1:03:05 Closing Remarks and Clinical Pearls Speaker biographies (Abbreviated) Zahra Khan is an educator and editor whose work emerges at the intersection of narrative, healing and disability justice, and liberation pedagogy.

Community 52

Community Education Patient-Centered Relationship 52

GeriPal

JULY 21, 2022

I don’t practice clinically in outpatient settings, and often the folks I’m seeing are there for other kinds of issues. Or somebody who has other physical cognitive problems at any age. Eric: Let’s say I have a panel of older adults that I’m seeing, or a palliative care outpatient clinic.

IT 102

IT Family Families Diagnosis 102

PEMBlog

MARCH 27, 2024

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.

Consulting 59

Consulting Individual Family Families 59