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  • Regulatory NewsRegulatory News

    FDA sends first warning letters for fraudulent marketing of antibody tests

    The US Food and Drug Administration this week issued its first set of warning letters for marketing adulterated or misbranded COVID-19 antibody tests.   The letters, sent to Medakit Ltd. of Hong Kong,  Antibodiescheck.com of United Arab Emirates, and Sonrisa Family Dental dba www.mycovidtest19.com of Chicago, cited a range of violations. These included offering test kits for sale in the US directly to consumers for at-home use without marketing approval, cleara...
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    FDA Adds New Q&As to Lab Controls Section of CGMP Guidance

    The US Food and Drug Administration (FDA) on Wednesday added three new questions and answers to its Laboratory Controls questions and answers (Q&A) on Current Good Manufacturing Practices (CGMP) guidance. The new Q&As discuss instrument calibration standards for chromatographic systems, system suitability and trial injections.   On the issue of trial injections, where a sample of a lot is injected into the chromatographic system with the intention of obtaining an unoff...
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    FDA Leadership Calls for LDT Reforms

    While championing advances made in diagnostic technology in recent years, top officials from the US Food and Drug Administration (FDA) are calling for a new regulatory framework for in vitro clinical tests (IVCTs) and laboratory developed tests (LDTs). The call comes as lawmakers from both parties on Thursday released a new 200-page discussion draft of a bill that would establish such a framework, incorporating many of the reforms FDA has recommended, including a pr...
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    FDA Hands Akorn 483 Over GMP Issues at New Jersey Site

    In an inspection report released Friday, the US Food and Drug Administration (FDA) details 11 observations from an inspection of Akorn’s Somerset, New Jersey facility in July and August of this year.   This is the second Form 483 Akorn has received in 2018. In May the company was handed a Form 483 listing a total of 13 observations from an inspection of the company’s Decatur, IL facility, the third inspection report issued for that facility in three years.   Form ...
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    FDA Announces Third-Party Review Pathway for Tumor Profiling Tests

    The US Food and Drug Administration (FDA) on Wednesday announced it has cleared a next-generation sequencing (NGS) test developed by Memorial Sloan Kettering Cancer Center (MSK) that can detect 468 unique gene mutations and other molecular biomarkers in a patient's tumor. The test, referred to as MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets), was already approved for use with samples from patients in New York by the New York State Department of ...
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    FDA Warns Lead-Testing Diagnostics Company

    The US Food and Drug Administration (FDA) on Monday sent a warning letter to Massachusetts-based Magellan Diagnostics, a subsidiary of Meridian Bioscience, finding the company made significant changes to its lead-testing devices without notifying the agency, among other violations. The warning letter, which follows an inspection of the North Billerica, MA, site last May and June, notes that Magellan made a "significant change by adding to the device labeling an ins...
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    FDA Approves First DTC Tests Evaluating Genetic Risk Information

    The US Food and Drug Administration (FDA) on Thursday authorized the first direct-to-consumer (DTC) genetic health risk tests for 10 diseases and conditions. The authorization for the genetic testing company 23andMe means individuals for the first time will be able to use these tests to understand their genetic predispositions for certain diseases and conditions without first seeing a doctor. “Consumers can now have direct access to certain genetic risk information,”...
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    Diagnostics: Bipartisan Duo Offers Bill to Alter Regulations

    The ongoing overhaul of diagnostic and lab-developed test (LDT) regulations turned another corner last week, with Reps. Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) releasing a discussion draft of a bill that would offer a new direction for the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS). The 215-page discussion draft, known as the Diagnostic Accuracy and Innovation Act (DAIA), draws some similarities to another dr...
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    FDA Further Explains Delay on LDT Guidance

    Two months after saying it would not finalize guidance on the regulation of lab-developed tests (LDTs), the US Food and Drug Administration (FDA) on Friday published a discussion paper with some hints as to how it would like the discussion and regulations on this thorny issue to move forward. As FDA explains, “LDTs play an increasingly important role in the provision of high-quality health care and many laboratories perform good validation of their LDTs and provide high...
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    FDA Delays Finalization of Lab-Developed Test Draft Guidance

    The US Food and Drug Administration (FDA) on Friday said it will wait for the new administration and halt the finalization of guidance that would have changed the way lab-developed tests (LDTs) are regulated. Tara Goodin, press officer for FDA told Focus : "FDA believes that patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions—inaccurate or false test results can harm individual patients. We have been...
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    FDA Offers New Draft Guidance on How to Co-Develop IVDs, Therapeutics

    The age of precision medicine, with treatments targeted to specific patients based on a companion test identifying the need for such a treatment, is pushing the US Food and Drug Administration (FDA) to release new and more detailed draft guidance on how companies can co-develop a therapeutic alongside what the agency is calling an in vitro companion diagnostic device, or IVD companion diagnostic. The draft released Thursday, entitled "Principles for Codevelopment of an...
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    Regulating Precision Medicine: Capacity vs. Overreach

    As the boundaries between the clinic, the research lab and industry continue to shift, researchers are calling on the US Food and Drug Administration and other similar regulators worldwide to tread carefully in how they effectively facilitate the practice of precision medicine. In an article published online this week in the Journal of Law and the Biosciences , titled “Precision medicine: drowning in a regulatory soup?” a group of mostly Australian researchers note that...