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    EMA Issues Draft Guidance on Post-Authorization Efficacy Studies

    The European Medicines Agency (EMA) today issued draft scientific guidance intended to help sponsors design post-authorization efficacy studies (PAES). The guidance, which comes a year after a new regulation, known as the Commission Delegated Regulation (EU) No 357/2014, established circumstances in which EU regulators could require PAES for all medicines. In the past, PAES were typically only required for medicines approved conditionally or under exceptional circumstanc...
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    Industry Seeks More Specifics on FDA's Flexibility With Orphan Drug Guidance

    Two industry associations and a rare disease patient advocacy group say they want the US Food and Drug Administration (FDA) to clarify its "regulatory flexibility" with orphan drug reviews. Challenges in Orphan Drug Development In August, FDA released a draft guidance intended to address the most common issues faced by drugmakers developing treatments for rare diseases . The guidance notes that FDA's "regulations provide flexibility in applying regulatory standards" a...
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    GAO Finds Majority of Postmarket Surveillance Studies FDA Ordered for Devices are Inactive

    Nearly 90% of the postmarket surveillance studies the US Food and Drug Administration (FDA) ordered over the past seven years were categorized as inactive, though some of these studies were added to other ongoing studies, according to a new Government Accountability Office (GAO) report. Rep. Rosa DeLauro (D-CT) requested the GAO look into the postmarket studies of devices ordered by FDA, and this latest report investigates the types of devices for which FDA has ordered a...
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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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    European Commission Responds to 'Stop Vivisection' Campaign

    The European Commission (EC) has responded to a campaign calling for an end to animal testing in the EU, saying animal testing is still necessary, but promising to accelerate efforts to reduce the need for animal testing. Background In March 2015, the Stop Vivisection campaign submitted a European Citizens' Initiative to the EC, calling for the commission to repeal Directive 2010/63/EU and replace it with new legislation that would phase out animal testing. A Eu...
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    To Fight Antimicrobial Resistance, FDA Asks Animal Drugmakers for More Information

    A new regulation proposed by the US Food and Drug Administration (FDA) would require manufacturers and sponsors of veterinary antibiotics used in food-producing animals to collect and submit data regarding the use of the drugs in specific animal species. The data is intended to help advance FDA's efforts to promote the "judicious use" of antibiotics as part of a broader initiative to stem the rise of antimicrobial resistance (AMR). Under the 2008 Animal Drug User Fee...
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    FDA Grants Approval to New Drug Under Rarely Used Animal Rule Pathway

    A new drug approved by the US Food and Drug Administration (FDA) to treat patients afflicted with the plague was reviewed under a rarely used regulatory pathway meant to sidestep ethical and practical testing concerns. Background In 2002, FDA passed the  Animal Efficacy Rule  ("Animal Rule"), a regulation which permits the approval of some products based on safety testing in humans and efficacy testing in animals. The rule, located at  21 CFR 314.600-650  (drugs) and  ...
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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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    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...