• Regulatory NewsRegulatory News

    Senators Say FDA Import Regulation Would Harm Vulnerable Consumers

    • 10 July 2014
    Four US senators are pressuring the US Food and Drug Administration (FDA) to walk back a rule proposed by the agency in May 2014 that would make it more difficult to import unapproved drugs into the US. Background The proposed rule, Administrative Destruction of Certain Drugs Refused Admission to the United States , is meant to tweak the agency's pharmaceutical import provisions under Section 801(b) of the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under the ...
  • Regulatory NewsRegulatory News

    Regulators Extend Comment Period on Proposed Overhaul of Device Reclassification System

    The US Food and Drug Administration (FDA) is extending by several months the comment period on a proposed rule which would make it easier for the agency to classify and reclassify medical devices in accordance with their perceived risk. Background The proposed regulation is required under a 2012 law known as the  Food and Drug Administration Safety and Innovation Act (FDASIA) .  Section 608 of the law  called for FDA to be given the authority to make classificati...
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    Six New FDA Regulations to be Introduced in 2014, Including Major Change in IND Reporting

    The US Food and Drug Administration (FDA) has released an updated list of regulations it is planning to seek in 2014, known as its "Unified Agenda," outlining six new rules it says it intends to propose in 2014. DQSA-Related Rules Several are related to FDA's new authority under the Drug Quality and Security Act (DQSA) of 2013, which contains numerous provisions intended to enhance FDA's ability to regulate compounding pharmacies. For example, FDA plans to issue pro...
  • FDA's Proposal to Cut Down on Risks Listed in Drug Ads Wins Praise From Drug Companies

    In February 2014, the US Food and Drug Administration (FDA) announced that it wanted to revisit how it regulates the "major statement" of its drug advertisements, calling them potentially too long, leaving consumers more confused than informed. Now the pharmaceutical industry is weighing in on FDA's call for comments, supporting both its call for additional research and its goal of easing current requirements. Background At present, companies are required to present th...
  • House Legislators Want FDA to Discuss 'Alternatives' to Generic Labeling Rule

    A large group of House Republicans is once against raising questions about the US Food and Drug Administration's development of a rule that would change the way generic drug labels are regulated, saying it has "significant questions" about the involvement of a group of trial lawyers in the process and is interested in proposing its own "alternative approaches." Interested in learning more about FDA's generic drug labeling rule? Check out our Regulatory Explainer o...
  • Regulatory Explainer: Understanding the Regulation of Generic Drug Labels

    Regulatory Focus'  ongoing series of  Regulatory Explainers  take complicated regulatory topics and make them simple enough for anyone to understand. In our latest Regulatory Explainer, we are taking a look at a new attempt by the US Food and Drug Administration (FDA) to change the way it regulates generic drug labeling and the controversy that it is causing within industry. Alright, Start From the Beginning: What's a Generic Drug? In general, most drug...
  • In Response to Legislators, FDA Defends Proposed Generic Drug Labeling Rule

    The US Food and Drug Administration (FDA) is defending itself against critics of its proposed generic drug labeling rule, which would change the way generic drug manufacturers are able to update their labels to reflect emerging or established safety risks. Background Regulatory Focus  has written extensively about the  proposed rule , including its  legal background , initial  calls by legislators for reform , FDA's  early plans for a rule chan...
  • Opponents, Proponents of Generic Drug Labeling Rule Unleash New Arguments and Supporters

    As legislators prepare to debate the merits of a new proposal by the US Food and Drug Administration (FDA) to change the way generic drug labels are updated to reflect new safety risks, supporters on both sides of the debate are marshalling support for their arguments. Background Focus has written extensively about the proposed rule , including its legal background , initial calls by legislators for reform , FDA's early plans for a rule change , the reaction of l...
  • FDA, HHS Release Regulatory Agenda for 2013

    The US Department of Health and Human Services (DHHS) has released its Unified Agenda for the coming year, including dozens of final and proposed regulations set to be released by the US Food and Drug Administration (FDA). The final list, which does not include draft or final guidance documents, which are contained in other center-specific lists, is nevertheless extensive. Many of the planned regulations are holdovers from prior lists, but several are new. One, in par...
  • Proposed Study to Look at Effect of Advertising, Social Media on Prescribing Habits

    The US Food and Drug Administration (FDA) is preparing to conduct a survey of prescribing healthcare professionals regarding their assessment of promotional advertising generated by the pharmaceutical industry, including advertising through social media channels, according to a 10 October posting in the Federal Register . "FDA has an interest in determining the attitudes, perceptions, and opinions of healthcare professionals with prescribing authority regarding such...
  • Disease-information Enhanced Advertisements May Be Misleading Consumers, Says FDA

    The US Food and Drug Administration (FDA) seems to be in favor of un-branded disease awareness commercials. In a Federal Register posting on 20 June, the agency says it is aware of research saying consumers find the advertisements both more helpful and less intrusive than branded product commercials, which is in line with the agency's goals to "encourage the communication of accurate health messages." What it's not supportive of, however, is when disease information is ...
  • European Regulators Want New Gout Guidelines

    The European Medicines Agency (EMA) on Thursday released a new concept paper calling for new guideline to assist sponsors conducting clinical trials on medicinal products intended to treat gout. Gout, an inflammatory arthritis brought on by the introduction of monosodium urate crystals within a patient's joints and tissues, is currently estimated to affect 3.9% of adults, with nearly three times as many men being affected as women. In its 14 June concept paper, EMA note...