• Regulatory NewsRegulatory News

    Senators Grill CMS on Incorporating UDIs Into Insurance Claims Forms

    Senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA) questioned the Centers for Medicare and Medicaid Services' (CMS) opposition to incorporating the unique device identifier (UDI) for medical devices into insurance claims forms. By not adding UDIs to insurance claims forms, Warren and Grassley warn that Medicare is making it more difficult to monitor device safety, which has resulted in millions of claims that could have been avoided with better monitoring. In ...
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    Senators Urge Obama to Take Action on Drug Prices

    Policy solutions to bring down the rising tide of prescription drug prices should be included in next year’s budget, eight senators said in a letter sent to President Barack Obama on Tuesday. Examples of ways Obama could help to lower drug costs include requiring drugmakers to provide rebates on prescriptions for Medicare Part D low-income subsidy enrollees “in the same way that it does already for Medicaid recipients,” the senators said, noting that about $120 billion c...
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    New House Bill Seeks to Allow HHS to Negotiate Medicare Drug Prices

    Rep. Jan Schakowsky (D-IL) on Thursday introduced a new bill that would allow the Department of Health and Human Services (HHS) secretary to negotiate Medicare Part D prices for either sole-source drugs or biologics and are not manufactured by more than two drug companies. Under the bill, drug manufacturers and the secretary would have 90 days to negotiate the price of a drug covered by Medicare Part D. If the two parties fail to reach an agreement after the allotted tim...
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    How Often Does FDA Withdraw Drugs Using Discontinuation Petitions? Very Rarely

    Not all drugs approved by the US Food and Drug Administration (FDA) stand the test of time. In some cases, the drugs are eventually removed from the market, either because they are unsafe, ineffective or just because their sponsor no longer feels like making them. But how often do these withdrawals take place, and to what extent do they reflect concerns about the safety or efficacy of a drug? Background The question is the subject of a new analysis by Hyman, Phelps & Mc...
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    Attorneys General Call on FDA to Strengthen Supplement Safeguards

    • 03 June 2015
    The attorneys general of New York and Indiana are urging the US Food and Drug Administration (FDA) to "overhaul" the way in which it regulates the manufacture of dietary supplements. Background In the US, dietary supplements are defined as an oral product containing a "dietary ingredient," including vitamins, minerals, herbs, botanical ingredients, amino acids or other dietary substance. Despite commonly being used to support consumer health, dietary supplements are re...
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    FDA Grants Approval to New Drug Under Rarely Used Animal Rule Pathway

    A new drug approved by the US Food and Drug Administration (FDA) to treat patients afflicted with the plague was reviewed under a rarely used regulatory pathway meant to sidestep ethical and practical testing concerns. Background In 2002, FDA passed the  Animal Efficacy Rule  ("Animal Rule"), a regulation which permits the approval of some products based on safety testing in humans and efficacy testing in animals. The rule, located at  21 CFR 314.600-650  (drugs) and  ...
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    FDA Guidance Aimed at Helping to Protect Fish from Certain Drug Products

    A new draft guidance document issued by the US Food and Drug Administration (FDA) calls on sponsors of estrogenic, androgenic or thyroid activity drugs to interact with regulators early on in the review process to help assess the potential impact of their drugs on aquatic wildlife. Background FDA's requirements to conduct environmental testing are the result of the National Environmental Policy Act (NEPA) of 1969. The law required federal agencies to determine t...
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    US FDA Amends eMDR Rules to align with Unique Device Identification Program

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. US medical device regulators at the Food and Drug Administration (FDA) have issued correcting amendments  to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system. All changes will affect federal regulation 21 CFR Part...
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    FDA Says it's OK With Modernizing the Clinical Trial Informed Consent Process

    New guidance issued by the US Food and Drug Administration (FDA) could make it easier for companies to conduct clinical trials by explaining how federal regulators will permit companies to use electronic media like interactive websites to help facilitate the informed consent process. Background In the US, clinical trials are regulated by FDA and the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under Chapter 21, Section 50.25 of the Code of Federal Regulations (...
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    23 Million Hours Spent Each Year Complying With Clinical Trial Requirements, FDA Estimates

    Conducting clinical research is difficult. Patients need to be protected, protocols adhered to, results meticulously recorded and hundreds of regulations followed. And when all is said and done, the US Food and Drug Administration (FDA) estimates that complying with its clinical trial regulations takes almost 23 million hours each year. Background FDA regulates clinical trials under Chapter 21 of the Code of Federal Regulation , Section 312 (21 CFR 312). The section ...
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    FDA Updates Adverse Event Reporting Requirements for Tissue, Cellular Products

    When you hear the term "adverse reaction" in the life sciences industry, you're likely to immediately think about pharmaceutical or medical device products. But as a new guidance document from the US Food and Drug Administration (FDA) makes clear, cellular and tissue products are also subject to reporting requirements. Background The new draft guidance document relates to human cells, tissues and cellular and tissue-based products—better known by their acronym, HCT/Ps. ...
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    21 CFR Part 11: The Ins and Outs of One of FDA's Most Difficult Rules

    Introduction 1992 was a different time, when the Internet was still in its infancy and email as a corporate tool was only just beginning to take hold. In the life science industry, there were dreams—then unrealized—of a completely electronic and totally paperless office. And at the US Food and Drug Administration (FDA), regulators were only just beginning to realize the potential effects digital data management systems could have on product development. It was around th...