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  • Regulatory NewsRegulatory News

    New Study Looks at FDA's Use of Social Media to Communicate on Drug Safety

    A new study looking at the US Food and Drug Administration's (FDA) use of social media to communicate about drug safety finds that the agency could improve its impact by developing social media strategies and taking a more active role on web platforms. The study, conducted by researchers at Harvard Medical School, Northeastern University, Boston Children's Hospital and The Ohio State University, and funded by FDA's Center for Drug Evaluation and Research, looks specifica...
  • Regulatory NewsRegulatory News

    Best Practices for IND Sponsor Communications: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) last week finalized guidance from 2015 on the best practices for communications between investigational new drug application (IND) sponsors and FDA. The guidance describes what to expect in milestone meetings (i.e. pre-IND, end-of-Phase 1 and Phase 2 and pre-NDA/BLA [new drug application/biologics license application] meetings) and how sponsors and FDA work collaboratively during the drug development process. In addition, ...
  • Feature ArticlesFeature Articles

    Medical Product Communications Consistent With FDA-Required Labeling Draft Guidance: Navigating the Gray Zone

    This article discusses the changing landscape for promotional review regarding the shift in evidentiary standards introduced in the 2017 Draft Guidance. It also highlights industry perspectives for consideration to companies looking to apply the principles outlined in the Draft Guidance or in preview to what could be addressed in a future revision. Introduction Regulatory advertising and promotion professionals are accustomed to working amidst ambiguity or in the gray...
  • Feature ArticlesFeature Articles

    New Developments in Payor Communications: Are 20 Years of Uncertainty Over?

    This article discusses the state of FDA guidance relating to the US Food and Drug Administration Modernization Act (FDAMA-114), particularly in the area of Healthcare Economic Information (HCEI), and looks at the questions requiring clarification in order for industry to be able to effectively change how economic and other clinical information is communicated to payors and similar groups. The author also evaluates elements of FDA's 2017 Draft Guidance. Introduction In...
  • Regulatory NewsRegulatory News

    Medical Product Communications: Industry Seeks to Reform FDA Draft Guidances

    With a flood of new comments, pharmaceutical, biotech and medical device companies are seeking changes to two draft guidances explaining the US Food and Drug Administration's (FDA) evolving policies on industry communications with payers and claims that adhere to a drug's label. Introduced in January, the draft Q&A documents detail how drug and device firms can discuss unapproved medical products with payers in ways that are "truthful and non-misleading," as well...
  • Regulatory NewsRegulatory News

    House Bill Seeks to Expand Off-Label ‘Scientific Exchange’ Between Industry, Doctors

    While the US Food and Drug Administration (FDA) attempts to re-work its policy on off-label use communications, Rep. Morgan Griffith (R-VA) has introduced a new bill that would further allow pharmaceutical companies to discuss such uses with physicians. GOP representatives have criticized FDA recently for failing to update its policies on off-label use communications as the agency has lost several recent court cases on the issue , and has questioned the need for loos...
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    Truthful and Non-Misleading: FDA Looks to Clarify Policies on Medical Product Communications

    When is off-label marketing considered free speech? And when should such communications, whether they are directed at doctors, insurers or the public be considered in violation of the law or US Food and Drug Administration (FDA) regulations? FDA on Wednesday attempted to answer these questions and more with the release of two new draft guidance documents and a 63-page memorandum on public health interests and First Amendment considerations related to off-label communica...
  • Regulatory NewsRegulatory News

    FDA Begins Process of Overhauling Off-Label Communications Regulations

    The US Food and Drug Administration (FDA) on Wednesday announced a new two-day public meeting to address a comprehensive review of its regulations and policies governing firms’ off-label communications on unapproved uses of approved drugs and medical devices. The hearing comes as FDA has come under fire recently for its limiting of what drug and device industries consider to be “free speech.” In March, FDA settled a lawsuit with drugmaker Amarin after the US District C...
  • Regulatory NewsRegulatory News

    GAO Offers Sharp Critique of FDA’s Lack of Measurable Regulatory Science Goals

    The Government Accountability Office (GAO) on Wednesday released two reports criticizing the Food and Drug Administration (FDA), one that says FDA lacks measurable goals to assess its progress in advancing regulatory science, and another that says FDA should better coordinate between its medical product centers. On the regulatory science front, GAO notes that FDA issued strategic planning documents in 2011 and 2013 to guide its regulatory science and identify priority...
  • Regulatory NewsRegulatory News

    Aspirin-Containing Heartburn Drugs: FDA Warns of Serious Bleeding Risk

    The US Food and Drug Administration (FDA) on Monday warned consumers about the risk of serious bleeding when using over-the-counter (OTC) aspirin-containing antacid drugs to treat heartburn, sour stomach, acid indigestion or upset stomach. The widely used OTC products already have warnings  about this bleeding risk in their labels, though Dr. Karen Mahoney, Deputy Director and Supervisory Medical Officer in FDA’s Division of Nonprescription Drug Products, noted that a r...
  • Regulatory NewsRegulatory News

    FDA: Fluoroquinolone Risks Outweigh Benefits in Some Cases

    The US Food and Drug Administration (FDA) on Thursday advised that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections (UTIs) who have other treatment options. “For patients with these conditions, fluoroquinolone should be reserved for those who do not have alternative treatment options,” the agency said in its safety notification. ...
  • Regulatory NewsRegulatory News

    Antipsychotic Label Updated With New Impulse-Control Side Effects

    • 03 May 2016
    The US Food and Drug Administration (FDA) on Tuesday warned that compulsive or uncontrollable urges to gamble, binge eat, shop and have sex have been reported with the use of Otsuka’s antipsychotic drug aripiprazole (brand names include Abilify, Abilify Maintena, Aristada) or generic versions from Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals and Torrent Pharmaceuticals. “These uncontrollable urges were reported to have stopped when the medicine was disconti...