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    Personalized nutrition

    Personalized nutrition is founded in evidence-based science and draws on individual-specific information to help consumers promote positive, sustainable dietary behavioral change resulting in measurable benefits in health improvement and maintenance, or disease-specific benefits. This article provides a comprehensive definition of personalized nutrition and examines its regulation globally and in the EU in regard to data protection, product qualification, and claims.   ...
  • Regulatory NewsRegulatory News

    US Intervenes in False Claims Suit Against Alere, Arriva Medical

    The US Department of Justice (DOJ) announced Tuesday that federal prosecutors intervened in a lawsuit under the False Claims Act whistleblower provisions against a former supplier of blood glucose monitoring supplies. The case alleges that Arriva Medical and its parent company Alere “submitted or caused false claims to the Medicare program for medically unnecessary glucometers and paid kickbacks to Medicare beneficiaries in the form of free glucometers and copayment w...
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    Microbiome, Diet, Health, and Disease: Policy Needs to Move Forward

    This article covers policy needs concerning the rapidly evolving field of microbiome and diets with respect to health and disease. It captures some key outcomes of a multi-stakeholder dialogue (Brussels, May 2016), spearheaded by a joint effort of the Organisation for Economic Co-operation and Development (OECD) and the Department of Economy, Science and Innovation of the Flemish Government (Belgium), to help design and/or interpret regulatory frameworks for food and dru...
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    Sen. Warren: Adding UDIs to Medicare Claims Forms Should be a 'No-Brainer'

    Millions of Americans are implanted with various medical devices each year, though the Centers for Medicare & Medicaid Services (CMS) still lacks the ability to track which devices prematurely fail or are recalled based on claims data. At a hearing Tuesday at the Senate Health, Education, Labor and Pensions (HELP) committee, Sen. Elizabeth Warren (D-MA) called on CMS to update the Medicare claims form to include a line for the unique device identifier (UDI) to kno...
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    The Life and Times of a Promotional Claims Compendium

    This article discusses developing a "promotional claims compendium" to review pharmaceutical marketing materials. It highlights the advantages of using a compendium for a variety of purposes and the potential value it could bring to not only the review team, but the entire organization. Introduction Reviewing promotional materials is a necessity in the pharmaceutical industry. Rules and regulations implemented by the US Food and Drug Administration (FDA) regarding pro...
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    Bioequivalence Studies of Solid Oral Dosage Forms Overview

    The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US. Introduction 'Generic' drugs offer a significant cost saving and are ...
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    Committee Recommends Adding UDIs to Insurance Claims Forms

    The group tasked with developing the standards for insurance claims forms on Wednesday recommended including unique device identifiers (UDI) on claims forms. Specifically, the Accredited Standards Committee X12 recommended that the device identifier portion of a UDI be included when high-risk devices are implanted or removed "due to safety concerns about premature failure." The recommendations are now undergoing a three-month consultation ending on 2 May 2017. Following...
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    HHS Inspector General Calls on CMS to Incorporate UDIs Into Claims Forms

    In a letter to the Centers for Medicare & Medicaid Services (CMS) Acting Administrator Andy Slavitt on Friday, Department of Health and Human Services (HHS) Inspector General Daniel Levinson calls on CMS to work with the Accredited Standards Committee (ASC) X12 to incorporate unique device identifiers (UDIs) for implantable devices into insurance claims forms. According to Levinson, doing so could help CMS keep track of the costs associated with recalled and defective me...
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    Grassley and Warren Call for UDIs to be Added to Health Insurance Claims Forms

    Incorporating unique device identifiers (UDIs) into health insurance claims forms could help improve the postmarket tracking of medical device safety concerns and performance, Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) wrote in a letter earlier this week to the chair of an Accredited Standards Committee. The Virginia-based committee is tasked with recommending changes to electronic claims forms, with the latest version of standards slated for release 1 Dece...
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    Industry Questions FDA Study on Efficacy Claims in DTC Pharma Ads

    Pharmaceutical companies AbbVie, Eli Lilly and Merck are raising new questions about the Food and Drug Administration’s (FDA) plan to investigate the impact on consumer perceptions of prescription drugs if efficacy claims are included in the advertisements. The Office of Prescription Drug Promotion’s (OPDP) study of direct-to-consumer (DTC) print advertising of drugs, first announced in July 2015 , will also seek to better understand if consumers make different cho...
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    Pew: Insurance Claims Must Include UDIs to Track Device Safety

    The Pew Charitable Trusts says that adding unique device identifiers (UDIs) to insurance claims forms is critical to the success of several federal initiatives to improve medical device safety and patient care. Dr. Josh Rising, director of healthcare programs at Pew, told Focus on Wednesday about his organization's efforts to improve device surveillance and how incorporating UDIs into claims forms can aid those efforts. "The goal of Pew's medical device project is to ...
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    Electronic Application Forms Mandatory for EU Centralized Procedure

    Beginning today, the European Medicines Agency (EMA) will require companies to use new electronic application forms (eAF) for all medicines applying to the centralized procedure. Background In March 2012, EMA piloted the use of electronic application forms as part of its efforts to modernize the marketing authorization process. Since then, EMA has allowed companies to submit their initial marketing authorization applications in either electronic or paper format. Then i...