News & Analysis as of

Precision Medicine Initiative (PMI) Diagnostic Tests

Holland & Knight LLP

Sequence of Events: Genetic Testing Offers Significant Promise, But Coverage and Access Limited

Holland & Knight LLP on

In the world of rare diseases, patient testimonies about the extreme difficulties of receiving an accurate diagnosis for an illness are numerous. For instance, one woman, sick for most of her young life, was not properly...more

White and Williams LLP

Digital Twin Technology in Healthcare

White and Williams LLP on

Imagine a future where personalized healthcare will provide every individual with the right treatment at the right time. Advances in precision medicine have already led to powerful new discoveries and treatments that are...more

Epstein Becker & Green

Next-Generation Sequencing: FDA Issues New Guidance for Genetic Tests

Epstein Becker & Green on

On July 6, 2016, the U.S. Food and Drug Administration (“FDA” or “Agency”) released the following two draft guidance documents on the oversight of next-generation sequencing (“NGS”) tests...more

Mintz

FDA Comes Through on Promise to Release NGS Device Draft Guidelines Expeditiously

Mintz on

Building on last year’s public workshops related to Next-Generation Sequencing (NGS) and expanding its efforts to advance the Obama Administration’s Precision Medicine Initiative, the FDA late last week released two draft...more

Foley & Lardner LLP

Despite Barriers, Community Speciality Clinics are Eager to Adopt Precision Medicine Tools

Foley & Lardner LLP on

Fueled by technological advances, scientific breakthroughs and significant financial investments, precision medicine (PM) has emerged as a promising approach to disease prevention and treatment. A multi-faceted solution to...more

Mintz - Health Care Viewpoints

ML Strategies Health Care Update – DNA Sequencing Workshop and Drug Pricing Developments

On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics....more

Mintz - ML Strategies

FDA Invites Genome Scientists to Come Play in the precisionFDA “Sandbox” - NGS Technologies Take Center Stage at Agency Campus

Mintz - ML Strategies on

On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public workshops engaged presenters and audience members on various...more

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