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    NICE to Work Earlier With Industry to Speed NHS Adoption of New Drugs, Devices

    The UK's National Institute for Health and Care Excellence (NICE) on Tuesday officially launched its Office for Market Access (OMA) to collaborate more closely with industry to accelerate the adoption of new drugs, devices and diagnostics by the National Health Service (NHS). Specifically, OMA will give commercial stakeholders access to a dedicated team at NICE that they can approach for inquiries relating to health technology evaluation, as NICE is responsible for...
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    EMA Updates Two Pharmacovigilance Guidelines

    Today, the European Medicines Agency (EMA) released two revised guidelines, one final and one draft, to clarify certain aspects of pharmacovigilance in the EU. The two guidelines include a draft version of Module VIII – Post-Authorisation Safety Studies (Rev 2) , which is expected to come into effect in early 2016, and Module IV – Pharmacovigilance Audits (Rev 1) , which takes effect on 12 August 2015. Background Pharmacovigilance is the process of monitoring the use...
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    EMA Hopes to Boost Drug Safety in Scientific Advice Pilot

    In an effort to boost the safety of approved drugs, the European Medicines Agency (EMA) is piloting a new procedure that would allow companies to seek the agency's advice on designing post-authorization safety studies (PASS). Background Currently, EMA and its Scientific Advice Working Party (SAWP) offer scientific advice to companies developing medicines. The advice is primarily intended to help drugmakers design "trials that are scientifically sound and generate rob...
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    FDA to Study How Efficacy Information Affects Patients' Decisions in Drug Ads

    Does the inclusion of efficacy information in drug advertisements affect how patients perceive a drug, and if so, how would it affect their decision making? These are questions the Office of Prescription Drug Promotion (OPDP) at the US Food and Drug Administration (FDA) intends to answer through a two-part study just announced in the Federal Register. Background In addition to reviewing drug ads and promotional labeling "to ensure that the information … is not false ...
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    How Often Does FDA Withdraw Drugs Using Discontinuation Petitions? Very Rarely

    Not all drugs approved by the US Food and Drug Administration (FDA) stand the test of time. In some cases, the drugs are eventually removed from the market, either because they are unsafe, ineffective or just because their sponsor no longer feels like making them. But how often do these withdrawals take place, and to what extent do they reflect concerns about the safety or efficacy of a drug? Background The question is the subject of a new analysis by Hyman, Phelps & Mc...
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    FDA Drug Advertising Study Tracker

    The US Food and Drug Administration (FDA) frequently studies consumer behavior, particularly as it relates to how members of the public (and medical professionals) understand pharmaceutical advertising. Our FDA Drug Advertising Study Tracker keeps tabs on these studies and explains what they're trying to accomplish in plain terms.   Date Topic Study Summary January 2012 Corrective Advertising Study to assess whether and how corrective advertising—used to cor...
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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...
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    FDA Releases New Animal Rule Guidance With Focus on Vaccines and Animal Health

    The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens. Background In 2002, Congress authorized and FDA passed the Animal Efficacy Rule ("Animal Rule"), a regulation which permits the approval of some products based on safety testing...
  • FDA Says it Wants to Make Anticoagulants, Opioids and Diabetes Drugs Safer for Patients

    The US Food and Drug Administration (FDA) wants to fund studies that will help it increase the safety of pharmaceutical and biological products even after they've been approved, it has announced. Background The announcement was made on 21 February 2014 as a technical amendment to an earlier " broad agency announcement "-essentially a wish list of regulatory science initiatives FDA said it planned to spend as much as $50 million on in the coming months. The original a...
  • FDA Guidance Establishes When an IND May Not be Required to Conduct Human Studies

    The US Food and Drug Administration (FDA) has released a new final guidance document intended to assist sponsors in determining whether a research study involving human subjects may be conducted without first filing an investigational new drug (IND) application with US regulators. Background: The FMT Precedent In recent months, FDA has proven to be somewhat amicable to the idea of extending enforcement discretion-that is, expressing that it won't punish an entity-when h...
  • Adverse Event Database Identifies Two Drugs as Having Potential Safety, Efficacy Issues

    A just-released update of the US Food and Drug Administration's Adverse Event Reporting System (FAERS) indicates that two drugs, metroprolol succinate extended release and serotonin-3 receptor antagonist products, are on the agency's radar for potential problems. The FAERS update, which covers the period between January and March 2013, identified two problems, both of which have not yet led to regulatory action but are nevertheless leading to continued study and evalua...
  • How a Private Anti-Counterfeiting Initiative Could Pressure Regulators to Improve Drug Quality

    What happens when your local regulatory agency isn't known as being reliable or capable at overseeing the safety and quality of products in your country? In at least one country, consumers could soon have a private-sector solution to improve their ability to ensure their medicines are of sufficient quality and identity. That initiative, run by the Partnership for Safe Medicines India Initiative (PSMII), is a side project of the Partnership for Safe Medicines-a coalition ...