• Regulatory NewsRegulatory News

    Senate Democrats Call for FDA, NIH Funding Boost as Other Bills Emerge

    Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) on Thursday introduced a bill that would provide $5 billion per year in new funding for the Food and Drug Administration (FDA) and National Institutes of Health (NIH). The boost in funds for FDA and NIH, backed by the Health, Education, Labor & Pensions (HELP) Committee Democrats, comes almost a month after the committee, still looking to pass companion legislation to the House-passed 21st Century Cures bill , advan...
  • Feature ArticlesFeature Articles

    Integrating FDA Meetings into a Medical Device Regulatory Strategy

    This article focuses on the strategic use and suitability of a Q-Submission program. Introduction An often overlooked opportunity for a successful device regulatory strategy is the optimal use of a pre-submission meeting with the regulatory agency. Meeting with the US Food and Drug Administration (FDA) to request feedback on specific submission issues has been formalized into what is collectively called the Q-Submission (Q-Sub) Program. A detailed description of the...
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    Expert Committee: FDA Should Allow Mitochondrial Replacement Trials Under Certain Conditions

    While the US Food and Drug Administration (FDA) sits on the fence over whether to approve preclinical or clinical trials using mitochondrial replacement techniques (MRT) to help prevent the transmission of certain diseases passed from mother to child, the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine came out with a new report on Wednesday detailing how it believes FDA should allow such trials and regulate them. Background ...
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    Device Industry Calls for Clarifications to Draft Animal Studies Guidance

    The Advanced Medical Technology Association (AdvaMed) is calling on the US Food and Drug Administration (FDA) to clarify aspects of a recent draft guidance intended to set expectations for animal studies for medical devices. Draft Guidance FDA released the draft guidance, General Considerations for Animal Studies , for public comment in October 2015. The guidance is intended to assist industry in designing, conducting and reporting data from animal studies used to de...
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    FDA Unveils New Office of Dietary Supplement Programs

    As part efforts to elevate the regulation of dietary supplements, the US Food and Drug Administration announced on Monday the creation of the new Office of Dietary Supplement Programs (ODSP). The new office, which previously worked as a division under the Office of Nutrition Labeling and Dietary Supplements, comes as the supplement industry has more than quadrupled in the 20 years since the establishment of that first division – from about $6 billion to more than $35 bil...
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    EMA Outlines High-Level Strategy for Next Five Years

    Antimicrobial resistance, ensuring timely access to new drugs, increasing transparency and working to harmonize more regulations worldwide are all included in the European Medicines Agency’s (EMA) strategic plan through 2020. The new plan, unveiled Friday, offers 16 objectives around four themes: Contributing to human health, contributing to animal health and human health in relation to veterinary medicines, optimizing the operation of the network and contributing to th...
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    USP Signs Agreement With Russian Drug Regulator to Continue Developing Quality Standards

    USP CSO Jaap Venema (right) signs agreement with Russian FDA Roszdravnadzor. The US Pharmacopeial Convention (USP) and Russia's medical products regulator forged a three-year memorandum of understanding (MOU) earlier this week that will focus on harmonizing major pharmacopeial requirements and promoting the use of modern laboratory standards, among other things. The agreement, which is an extension of an existing MOU instituted in 2009, means USP and the Federal...
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    EMA Gearing up to Publish Clinical Data Ahead of New Clinical Trials Regulation

    The European Medicines Agency (EMA) is moving forward with its plan to release the clinical data used in marketing authorization applications. Background: Clinical Trials Regulation In April 2014, the European Parliament overwhelmingly passed a new regulation governing clinical trials, Regulation (EU) No 536/2015 , repealing Directive 2001/20/EC following a transition period lasting through 28 May 2016. One of the major changes in the new Clinical Trials Re...
  • RAPSRAPS' Latest

    Experts to Offer Ad, Promo and Labeling Advice at RAPS Virtual Event

    Advertising and promotion of healthcare products in the US are strictly regulated by the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). As the Internet and social media have become increasingly powerful forces in our everyday lives and important sources of information on personal healthcare decisions, regulators, marketers and healthcare companies all have had to contend with a slew of new challenges. On Wednesday, 3 June, RAPS...
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    FDA Plans New Regulation on Fixed-Dose Combinations, Co-Packaged Drugs

    • 22 May 2015
    The US Food and Drug Administration (FDA) plans to release two new regulations by the end of 2015, it announced this week. The announcement, contained in the latest edition of the US Unified Agenda , contains 33 proposed and final rules FDA says it hopes to publish by the end of calendar year 2015. In practice, however, some rules have remained on FDA's Unified Agenda for years. FDA's latest update of the Unified contains two additional regulations compared to its las...
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    To Fight Antimicrobial Resistance, FDA Asks Animal Drugmakers for More Information

    A new regulation proposed by the US Food and Drug Administration (FDA) would require manufacturers and sponsors of veterinary antibiotics used in food-producing animals to collect and submit data regarding the use of the drugs in specific animal species. The data is intended to help advance FDA's efforts to promote the "judicious use" of antibiotics as part of a broader initiative to stem the rise of antimicrobial resistance (AMR). Under the 2008 Animal Drug User Fee...
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    FDA's Electronic Drug Labeling Proposal Comes Under Fire

    The US Food and Drug Administration (FDA) is coming under fire from patient safety groups and US legislators who say the agency's attempt to require certain drug labeling information to be distributed electronically instead of on paper "package inserts" could put patients at risk. Background In December 2014, FDA released a long-anticipated proposed regulation, Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Prod...