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    Dietary supplement class actions: Recent overlap with traditional FDA enforcement

    This article provides an overview of class action lawsuits targeting the dietary supplement industry. Recent trends indicate that companies should look beyond regulatory compliance and consider how a “reasonable consumer” would interpret claims in labeling, even claims that comply with FDA requirements. There are also important steps companies can take to prevent these lawsuits, as well as defenses that courts seem increasingly willing to accept. By staying aware of the cl...
  • Regulatory NewsRegulatory News

    One-Time Marketing Status Reports Due in February, FDA Says

    The US Food and Drug Administration (FDA) is calling on all new drug application (NDA) and abbreviated new drug application (ANDA) holders to submit one-time written reports on whether their products are available for sale or if they have been withdrawn or were never made available for sale. Reports are due 14 February and are required under a provision from the law reauthorizing the user fee programs. "The NDA or ANDA holder can submit the one-time report to FDA ...
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    FDA Announces Streamlined Review Pathway for DTC Genetic Tests

    The US Food and Drug Administration (FDA) on Monday detailed its plans to make it easier for companies developing direct-to-consumer (DTC) genetic health risk (GHR) tests to get those tests on the market. To do so, FDA is proposing a model similar to a pilot for digital health products, by which companies can be pre-certified to market low-risk software-based devices following an assessment of their systems for software design, validation and maintenance. Similarly, F...
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    DTC Drug Ads: New Study Finds Perception of Risks Diluted by Lengthy Side Effects List

    A study on direct-to-consumer (DTC) drug advertising published Monday in Nature Human Behavior finds that consumers perceive drugs to be less risky when ads for the drug list all of its side effects compared to when only serious side effects are listed. "When commercials list severe side effects along with those that are most frequent…it dilutes consumers' judgements of the overall severity of the side effects," write authors Niro Sivanathan, associate professor of org...
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    FDA Launches Searchable Adverse Event Database for Drugs and Biologics

    The US Food and Drug Administration (FDA) on Wednesday launched a new searchable public dashboard for its adverse event database for drugs and biologics. Known as FAERS (FDA's Adverse Event Reporting System), the database contains some 14 million adverse event reports submitted to FDA by healthcare professionals, consumers and manufacturers for drugs and biologics. Its immediate release led to questions over certain deaths , whether they were linked to the drug's safety...
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    EMA and FDA to Begin Sharing Commercially Confidential Information

    Editor's note: this article has been updated with a statement from FDA clarifying that the agency must sign a confidentiality agreement with each EU country before unredacted inspection reports may be shared. As part of a landmark agreement forged in March, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) said Wednesday that they will soon share non-public and commercially confidential information, including trade secret information. The a...
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    FDA Officials Study Alternative Approach to Presenting Risk Info in TV Drug Ads

    A recent study by US Food and Drug Administration (FDA) officials and research firm RTI International suggests that an alternative approach to presenting limited risk information in direct-to-consumer (DTC) TV drug advertising may improve consumers' ability to recall those risks. According to the study, limiting the risk information to only serious and actionable risks combined with a disclosure letting viewers know that not all the drugs' risks were presented also impro...
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    GAO: FDA Improved Expanded Access but More Clarity Necessary

    With the rise of Right-to-Try legislation across states in the US, it might seem like patients with serious or life-threatening ailments and no other comparable medical options might have difficulties in obtaining access to investigational drugs outside of a clinical trial because of the US Food and Drug Administration (FDA). But a new Government Accountability Office report released Tuesday lends credence to many who have voiced concerns with the Right-to-Try laws,...
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    EMA Offers New EudraVigilance Checklist for Sponsors, MAHs

    The European Medicines Agency (EMA) on Monday published a checklist to help marketing authorization holders (MAHs) and sponsors prepare for the technical changes ahead of the launch of the new EudraVigilance adverse event system on 22 November 2017. The checklist features general testing instructions and easy-to-follow steps to assist sponsors and MAHs in the transition. In addition, EMA notes that the ICH E2B(R3) Implementation Guide and the EU ICSR Implementation...
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    FDA Offers Updated Form for Field Alert Reports

    The US Food and Drug Administration (FDA) on Thursday released an updated version of its automated Field Alert Report (FAR) form, following the conclusion of a successful four-year pilot program. Under federal regulations, sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) are required to submit FARs to FDA within three days of being alerted to a potential safety issue, such as a labeling mix-up or bacterial contamination. In May 2013...
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    FDA Warns B. Braun Medical’s California Plant for Repeat Violations

    The US Food and Drug Administration (FDA) earlier this month sent a warning letter to B. Braun Medical’s Irvine, CA-based manufacturing facility for repeat violations also uncovered during inspections in 2013, 2014 and 2015. FDA found in its latest inspection from 18 April to 11 May 2016 that B. Braun’s "quality unit was not effectively exercising its responsibilities, particularly for investigating product defect complaints, manufacturing deviations, and adverse t...
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    FDA Approves First DTC Tests Evaluating Genetic Risk Information

    The US Food and Drug Administration (FDA) on Thursday authorized the first direct-to-consumer (DTC) genetic health risk tests for 10 diseases and conditions. The authorization for the genetic testing company 23andMe means individuals for the first time will be able to use these tests to understand their genetic predispositions for certain diseases and conditions without first seeing a doctor. “Consumers can now have direct access to certain genetic risk information,”...