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  • Regulatory NewsRegulatory News

    Proposed Rule Would Revise Regulations on Fixed-Combination Drugs

    The US Food and Drug Administration (FDA) is proposing a new rule that would apply its regulations on prescription fixed-combination drugs to a variety of nonprescription fixed-combination and co-packaged drugs, as well as to combinations of over-the-counter active ingredients. Under its authority to require evidence demonstrating that prescription fixed-combination or co-packaged drugs and OTC ingredients provide enhanced safety or effectiveness and can be labeled as su...
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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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    How an FDA Proposed Rule for Tobacco Products Could Have a Big Impact on 'Intended Uses' for Devices, Drugs

    Late last month, the US Food and Drug Administration (FDA) unveiled a new proposed rule that many in the pharmaceutical and medical device regulatory communities may have glanced over without a thought because it seemed to pertain only to tobacco products. But on a second look, the rule, if finalized, could have a major impact on the intended use regulations for drugs and devices. For both drugs and devices, an intended use is determined by a manufacturer's expressions, ...
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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...
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    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...
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    FDA Cracks Down on Facebook Marketing With Four New Letters to Companies

    The US Food and Drug Administration (FDA) is increasingly paying attention to social media, and in particular Facebook, as companies use the social networking platform to market their products. Six Warning Letters in Six Months In at least six Warning Letters issued since October 2014, FDA has referenced promotional claims used to market products on Facebook. Warning Letter Issued to: Reason for Letter Date Issued Vitalab Co., Inc. Unapproved Claims 16 Octo...
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    FDA Reopens Debate Over Major Generic Drug Labeling Rule

    Despite rumors of its demise, the US Food and Drug Administration’s (FDA) controversial plan to allow generic drug companies to update their labels to reflect new and emerging safety information isn’t dead—not yet, at least. Background As Regulatory Focus has extensively reported in the past, FDA has long been interested in making it easier for all drug companies—not just innovative manufacturers—to update the safety labeling on drug products. Read our Regulatory ...