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  • Regulatory NewsRegulatory News

    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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    Antimicrobial Susceptibility: FDA Launches Test Website, Issues Guidance

    The US Food and Drug Administration (FDA) on Wednesday launched a new website aimed at improving access to information that can help healthcare professionals determine which drugs are most likely to work to treat bacterial or fungal infections. The website is part of an effort mandated by the 21st Century Cures Act to combat rising antimicrobial resistance by providing a central, easily accessible and up-to-date repository for antimicrobial susceptibility interpretive ...
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    Theranos Agrees to Two Year Ban, Refunds Every Arizonan Who Purchased a Blood Test

    As part of an agreement reached with Arizona attorney general Mark Brnovich, the medical device startup Theranos on Tuesday agreed to pay $4.65 million for about 1.5 million blood tests sold to more than 175,000 Arizonans. The deal was forged after Theranos said it ultimately had to void or correct over 830,000 test results, which was about 11% of all results. A day earlier, Theranos announced it would settle with the federal Centers for Medicare & Medicaid Se...
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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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    Pharma Companies Take Issue With FDA Proposal to Overhaul Nonclinical Study Regulations

    A group of the world’s largest biopharmaceutical companies, including Pfizer, Novartis, Celgene, Bristol-Myers Squibb and more than 170 others have offered their critiques and are seeking further clarifications on the US Food and Drug Administration’s (FDA) proposed rule to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies. The proposed rule, unveiled in August , would require a complete quality system approach for these safety ...
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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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    Democrats Call on Theranos CEO to Testify About Regulatory Shortcomings, Inaccurate Test Results

    A group of high-ranking House Democrats have launched an inquiry into blood testing startup Theranos over its adherence to clinical laboratory testing standards. Following inspections last year, the US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) each cited Theranos for a number of compliance issues. In a letter dated 30 June 2016, Reps. Frank Pallone (D-NJ), Gene Green (D-TX) and Diana DeGette (D-CO) call on Theranos CEO ...
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    Updated: The Next Theranos? FDA Warns Qiagen Over Faulty TB Test Device

    The US Food and Drug Administration (FDA) on Tuesday released a warning lettter for Maryland-based Qiagen over deficiencies with its blood test used for diagnosing tuberculosis (TB), noting multiple complaints for high false positive rates. FDA’s inspection found that Qiagen’s QuantiFERON-TB Gold (QFT) test device, first approved in 2005, “is adulterated … in that the methods used in or the facilities or controls used for, their manufacture, packing, storage, or installa...
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    Congressmen Question FDA Over Office of Laboratory Safety

    Rep. Fred Upton (R-MI), chairman of the House Energy & Commerce Committee, and Rep. Tim Murphy (R-PA) sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday questioning why the agency has not formulated a budget request or level of staffing for its Office of Laboratory Safety. The letter follows an April hearing at which FDA said it has taken “direct and definitive actions” to improve lab safety. That hearing came as a report fro...
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    FDA Clears First Zika Diagnostic for Emergency Use

    The US Food and Drug Administration (FDA) on Friday approved the first diagnostic to detect the Zika virus under its emergency use authorization (EUA) pathway, which allows the agency to authorize unapproved products during a public health emergency. The authorization is significant as there are currently no other approved diagnostics available to detect Zika, a mosquito-borne virus that has rapidly spread across much of Latin America and the Caribbean and is thought to ...
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    Two More Companies Questioned by FDA Over DTC Genetic Tests

    The US Food and Drug Administration (FDA) sent letters to two genetic testing companies for marketing direct-to-consumer pharmacogenetics tests. The letters, addressed to Healthspek and Genomic Express, claim that tests sold through the companies' websites meet the definition of a medical device and must be cleared by FDA before being marketed. FDA Letters to Genetic Testing Companies Company Test Name Indication or Claim Genomic Express  Clopidogrel (Pl...