• Regulatory NewsRegulatory News

    Tougher FDA Approval Process for Opioids Sought by Congress

    New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). Background The bill, the FDA Accountability for Public Safety Act (FAPSA) , is a response to FDA's regulation of opioid painkillers, and specifically one known as Zohydro. The drug was approved in October 2013 as a pure hydrocodone product lacking any physical characteristi...
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    Does FDA Need New Authority to Regulate Complex Generic Drugs?

    New legislation introduced in the US House of Representatives seeks a government investigation into the US Food and Drug Administration's (FDA) review of complex generic pharmaceuticals to consider whether the agency is in need of new regulatory authority. Background The bill, the Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 , was introduced on 24 March 2015 by Rep. Michael Burgess (R-TX), a former physician and member of the House Energy a...
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    Pharmaceutical Trade Groups Propose Overhaul of Drug Safety Update System

    In a rare show of unity, two trade groups respectively representing the branded and generic pharmaceutical industries have proposed an alternate policy meant to replace the US Food and Drug Administration's (FDA) controversial proposal to change the way in which generic drug labels are updated to reflect new safety risks. Background In November 2013, FDA  proposed a rule to allow  generic drug manufacturers to temporarily update their labels if they were made aware of n...
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    FDA Wants Public Input on How to Improve Drug Safety

    If you have an idea for what the US Food and Drug Administration's (FDA) pharmaceutical regulators should be working on, now is the time to speak up. In a Federal Register announcement on 19 March 2015, FDA said it "hopes to foster collaborations with external partners and stakeholders" to help address a long list of regulatory "needs and priorities" identified by its Center for Drug Evaluation and Research (CDER), which is in charge of regulating drug products. The...
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    South Korean Regulators to Require Clinical Data for Many Class IV Medical Devices

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. South Korea’s medical device market regulator, the Ministry of Food and Drug Safety (MFDS), will begin requiring clinical data for dozens of medical devices in January 2016 that currently can avoid such requirements if their equivalence to predicate devices already on the South Korean market can be shown. Among the  proposed list of devic...
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    EU Considers Major Revisions to Veterinary Medicines Regulations

    The European Parliament is considering major changes to how veterinary medical products are regulated in the EU. At the upcoming meeting of the Environment, Public Health and Food Safety (ENVI) committee on 18 March 2015, members will discuss a proposal for a new regulation which is intended to overhaul the regulation of veterinary medicines and streamline the European market for veterinary medicinal products. Background Veterinary and human medicines regulations in th...
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    Citing Disease Transmission Risk, FDA to Require Stronger Labels on Some Diabetes Injectors

    The US Food and Drug Administration (FDA) said it will require manufacturers of multi-dose diabetes pen devices to label their products with more prominent warnings that patients should not share the devices. In a 25 February 2015 safety announcement, FDA said the new warnings are meant to "reduce the serious risk of infection" when users share insulin pens and other injectable diabetes medications, "even [when] the needle is changed." "Sharing pens can result in the sp...
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    Australian Regulator Says Smoking Device too Similar to Inhaler

    The Therapeutic Goods Administration (TGA) this week issued a safety advisory over two smoking devices that bear strong resemblance to metered dose inhalers used to treat asthma and other medical conditions. TGA says the devices, known as the Puffit and Puffix-X, are designed to “burn vegetable material such as herbs or tobacco,” which is then inhaled as smoke. TGA’s Warning The agency fears that the products’ similarity to metered dose inhalers could create con...
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    EMA to Translate Safety Signal Recommendations

    In an effort to improve the timeliness and consistency of product information changes, the European Medicines Agency (EMA) is now translating recommendations in all official EU languages, plus Icelandic and Norwegian. Background In the EU, pharmaceutical companies are required to provide translations of product information to EMA after a product is authorized. The translations must be made in all official EU languages, including Icelandic and Norwegian. From time to ...
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    After Weathering Scandals, UK Appoints New Medical Device Oversight Official

    The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has appointed a prominent academic figure, Dr. Peter Nightingale, to be the chair of its newly formed expert group on medical devices—a position intended to help UK regulators strengthen oversight of the UK's medical device sector. Background In 2014, an independent review of the UK’s MHRA concluded that the agency needs to bolster its oversight of medical devices and increase its engagement with the ...
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    Obama: Let's Take Food Regulation out of FDA

    The US Food and Drug Administration (FDA) could stand to lose all of its authority to regulate food products, potentially including dietary supplements, under a new proposal unveiled by President Barack Obama this week. Background The proposal, contained within Obama's budget proposal for fiscal year 2016, would consolidate all regulatory authority for food under a "single new agency within The Department of Health and Human Services," according to the budget. "This ne...
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    MHRA Joins other UK Agencies on Consolidated Website

    The UK’s Medicines and Healthcare Products Regulatory Agency’s (MHRA) this week announced major changes to its website meant to incorporate it more thoroughly into the UK government's main website. MHRA announced its plans to move from the old website (www.mrha.gov.uk) to www.gov.uk/mhra in April 2014. The new website launched on 28 January 2015 with a design that incorporates feedback from users on how they use the MHRA website and the Drug Safety Update system. Diffe...