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Rare Disease Report - How FDA's Breakthrough Therapy Designation Program Changed the Rare Disease Space

On July 9, 2012, officials signed the Food and Drug Administration Safety and Innovation Act (FDASIA) which had a section within it that established a new designation—the Breakthrough Therapy Designation—which allows for expedited development and review of drugs to treat serious or life-threatening diseases if substantial evidence is provided.

 

STAT - New bipartisan bill would give FDA the power to add off-label uses to generic drug labels

A bipartisan duo of senators wants to give the Food and Drug Administration the power to add off-label uses to certain generic drug labels.

 

Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) introduced legislation late Thursday that would put in place new requirements on generic drug makers and FDA.

 

European Respiratory Review - Randomised controlled trials and real-life studies: two answers for one question

Real-life studies have become increasingly important in the scientific world in recent years. Although they have numerous limitations, they have the advantage of better representing the population with which we normally have to deal in our everyday clinical practice. Randomised controlled trials (RCTs) remain the most effective form of evaluation of the efficacy of a therapeutic intervention to date, but their selection criteria limit the recruitment of patients in upper or lower age ranges or suffering from multiple comorbidities.

The Cancer Letter - Oregon weighs plan to deny Medicaid payment for NGS as panel declares “no evidence of clinical utility”

The Oregon Health Authority is weighing a recommendation to deny Medicaid coverage for next-generation sequencing tests in the state.

 

If enacted, Oregonians who rely on Medicaid for cancer treatment will not be offered coverage for NGS testing. Mainstream oncologists and experts on disparities in cancer care say that this first-of-its-kind anti-genetic-testing policy will create an inferior standard of care for the poor in Oregon, depriving these patients of access to targeted therapies.

 

The ASCO Post - ASCO and Friends of Cancer Research Submit Recommendations to FDA Aimed at Reducing Barriers to Clinical Trial Participation

On August 8, ASCO and Friends of Cancer Research (Friends) submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration to broaden eligibility for participating in clinical trials by addressing five specific areas: minimum age requirements for trial enrollment; HIV/AIDS status; brain metastases; organ dysfunction; and prior and concurrent malignancies.

 

POLITICO - FDA STEPS UP CAMPAIGN FOR LEADING ON DIAGNOSTICS

Commissioner Scott Gottlieb is scaling up FDA efforts to assert control over laboratory developed tests, saying in a speech that the agency would take a flexible approach — but first needs the power to act. The FDA last month sent 59 pages of recommendations to lawmakers constructing a bill to regulate LDTs, the custom diagnostic tests that hospitals and clinical labs typically develop for their own use. The FDA has tried to regulate the industry before — with draft guidance in 2014, and with language in the 21st Century Cure Act that was later dropped after labs resisted.

Inside Health Policy - Gottlieb: LDT 'Collaborative Community' Idea May Offer Cancer Research Model

FDA’s recent proposal to establish “a collaborative community” of stakeholders to support the agency in its decision-making process for diagnostics regulation could also serve as “a compelling new paradigm” for the cancer research community, Commissioner Scott Gottlieb said at a Friends of Cancer Research event Thursday (Sept. 13).

 

Bloomberg - Risky Lab-Developed Medical Tests Back in FDA Crosshair

A potential resolution to a lingering debate on how the government should oversee laboratory-developed diagnostic tests would focus the FDA’s attention on the more cutting-edge and riskier screening tools.


At issue is a disagreement between device companies and clinical laboratory groups on what constitutes appropriate federal oversight of laboratory-developed test (LDTs), which are developed in a single laboratory, compared to the same type of diagnostics made by device companies.

BioCentury - ASCO Addresses Financial Barriers to Participation in Cancer Trials

The American Society of Clinical Oncology proposed four ways to lower financial barriers that impede cancer patients' ability to participate in clinical trials, including a recommendation to improve payer clinical trial coverage policies.

 

Regulatory Focus - FDA Looks to Build Diagnostics Framework Centered on Accuracy, Reliability and Safety

As Congress crafts new legislation on diagnostics to update a system first built in 1976, the US Food and Drug Administration (FDA) has offered feedback that will help to shape a modern framework whereby diagnostics can be relied on as accurate and safe, FDA Commissioner Scott Gottlieb said in a speech Thursday to the Friends of Cancer Research’s 7th Annual Blueprint for Breakthrough Forum.

 

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