NEW PRODUCTS

FDA Watch: Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests

There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]

GENETIC TESTING

FDA Watch: Agency Exempts Dozens of Tests from 510(k) Review

On Dec. 30, 2019, the U.S. Food and Drug Administration (FDA) published a final order exempting dozens of Class I and Class II medical devices that previously required 510(k) submission from 510(k) … [Read more...]

NEW PRODUCTS

FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval

Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to … [Read more...]

GENETIC TESTING

FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval

Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to … [Read more...]

FDA Watch: Agency Clears the Way for Approval of Blood-Based PSA Test

The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening. The reason it doesn’t directly recommend testing for all men in this age group is … [Read more...]

EMERGING TESTS

FDA Unveils New Process for Streamlined Review of IVD Tests Used in Cancer Drug Trials

Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, 2019, the US Food and Drug … [Read more...]

EMERGING TESTS

Emerging Tests: New Genetic Tests May Be Better than PSA Screening in Assessing Prostate Cancer Risk

The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening based on their specific circumstances. The reason that the USPTF does not directly … [Read more...]

NEW PRODUCT DEVELOPMENT

New Product Development: FDA Issues Final Guidance on IVD Oncology Trials

On Oct. 10, 2019, the FDA finalized guidance on an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic (IVD) in an oncology clinical trial is … [Read more...]

NEW PRODUCTS

FDA Watch: New Process for Simultaneous Review IVD Tests Used in Cancer Drug Trials

Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, the FDA issued final … [Read more...]

FDA WATCH

FDA Watch: New NGS Data Guidance May Ease Antiviral Drugs & Companion Test Approvals

A new FDA Technical Specifications document (Tech Doc) lists recommendations for sponsors on use of next generation sequencing data to secure approval of new antiviral drugs and related diagnostic … [Read more...]


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