• Regulatory NewsRegulatory News

    EMA to Monitor Select Medical Literature for Drug Side Effects

    The European Medicines Agency (EMA) is launching a new initiative to monitor selected medical literature to proactively identify suspected adverse drug reactions (ADRs) for some 400 active substances. Pharmacovigilance in the EU Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. In particular, regulators, companies and healthcare providers are responsible for monitoring drugs and reporting suspected ADRs. This informati...
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    New Drug Safety Monitoring Fees Come Into Effect in Europe

    User fees paid by pharmaceutical companies, intended to fund regulatory activities by offsetting their expense, are set to rise in Europe under a new regulation published this week. The fees are intended to pay for new pharmacovigilance activities—basically the monitoring of medicines after their initial approval—that were required under legislation passed in 2010 and amended in 2012. The law, known as the pharmacovigilance legislation , is intended to centrali...
  • Regulatory NewsRegulatory News

    EMA Establishes Pharmacovigilance Framework for New Literature Monitoring Efforts

    In regulatory circles, reading literature isn't something that's necessarily done for fun. Instead, regulatory professionals are frequently charged with reading up on the latest literature—scientific literature, that is—mentioning their products in the hopes of discovering reports of dangerous side effects or other potential problems, such as mix-ups or inadequate use or abuse. Background Regulators use reports based on this literature differently. In most regions...
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    Legal Group to FDA: Reprint Guidance Violates First Amendment, Existing Court Order

    Public comments submitted to the US Food and Drug Administration (FDA) regarding its guidance documents are generally tame, referring to matters for preference or a need to clarify vague sections. But in the case of a recent response to a new guidance on distributing reprints of scientific and medical literature, one group's message for FDA is a bit more confrontational: Make changes to the guidance— or else . Background In February 2014, FDA released a new draft guida...
  • FDA Data Mining Project Proposal Once Again Withdrawn

    Earlier this week, Focus reported that a data mining project once abandoned by the US Food and Drug Administration (FDA) for lack of funding had been resurrected by the agency. Now, just days after the agency announced the project's return, it is once again cancelling the project-for now. Background FDA's data mining proposal has been in the works for more than a year. In April 2013, the agency established a notice indicating that it wanted to work with an outside com...
  • FDA Resurrects Data Mining Project Once Left for Dead

    The US Food and Drug Administration (FDA) has resurrected a once-canceled project intended to better mine data about adverse drug reactions from literature reports. Background FDA regularly puts out requests for proposals and solicitations on the Federal Business Opportunities (FBO) website, and has regularly expressed a keen interest in methods of monitoring adverse event data. In April 2013, for example, it put out a notice indicating it wants a partner to help it bu...