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  • Regulatory NewsRegulatory News

    Interoperable Medical Devices: FDA Offers Design, Labeling Considerations

    With an eye on helping medical device manufacturers ensure their products can safely and effectively exchange data, the US Food and Drug Administration (FDA) on Monday released new draft guidance on how to design such interoperable devices, as well as recommendations for labeling. The advance of interconnected devices could be a boon for patient care, particularly in cases where device-specific information, such as unique device identifiers (UDIs), and patient-specific d...
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    MHRA Proposal Would Save Industry £5M Annually in Fees

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is proposing to reduce many of the industry fees it collects by 10-15%, and it will introduce a new fee for online pharmacies to cover the cost of implementing the EU Falsified Medicines Directive. Fee Reductions Earlier this year the UK's Department of Health conducted its triennial review of MHRA. As part of the review, the Department of Health recommended MHRA revise its fees to better "align incom...
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    Two-Day FDA Advisory Committee Meeting to Address Drug Compounding Questions

    The US Food and Drug Administration (FDA) will host a two-day public advisory committee meeting on 27 and 28 October to look into updating a list of bulk drug substances that should not be compounded, and another list of substances that can be compounded. Background The  Drug Quality and Security Act (DQSA)  of 2013 was passed in the wake of a deadly outbreak of fungal meningitis caused by  deficient compounding practices  at a Massachusetts-based company. Historicall...
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    FDA Reverses Long-Standing Policy of Not Publicly Posting Individuals' Comments

    As part of its shift to increase transparency, the US Food and Drug Administration (FDA) said on Thursday that beginning 15 October it will publicly post individuals' comments on the regulations docket. The new policy could potentially have an impact on lobbyists or other special interest groups submitting comments as individuals. "In 1995, FDA explained that it routinely reviewed all comments for obvious confidential information before placing the comments in the docke...
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    India Unveils New Online Submission System for Clinical Trials

    India's Central Drugs Standards Control Organization (CDSCO) has launched a new online submission system for clinical trials as part of efforts to increase transparency, accountability and efficiency in processing trial applications. CDSCO says the new online system will help in the collection and organization of information on sponsors, contract research organizations, investigators, ethics committees and trial subjects. The release of the submission system comes as...
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    India’s CDSCO Looks to Crack Down on Online Drug Sales

    An Indian government committee is looking to stem the spread of illegal sales of prescription medicines online. The prevalence of such illegal online pharmacies is pushing India’s Drugs Consultative Committee (DCC) to consider amending the country’s prescription drug law – known as the Drugs and Cosmetics Rules, 1945 – to stop the spread of websites willing to sell medicines without a prescription in India and abroad. According to a summary of the committee’s meeting fr...
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    EU Online Pharmacies Required to Display New Logo Next Month

    New rules to help consumers in the EU identify legitimate online pharmacies are set to take effect on 1 July 2015. The rules require online pharmacies operating in the EU to display a "common logo," and register with authorities in the member states they do business in. Background Recognizing the threat to public health and safety posed by falsified medicines sold online, in 2011 the European Parliament and Council adopted Directive 2011/62/EU , also known as the Fa...
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    FDA Considers Compounding Restrictions on Four Drugs, Including Acetaminophen

    The US Food and Drug Administration (FDA) is preparing to ask one of its newest advisory committees to decide if some compounding pharmacies should be allowed to make four drugs, including the widely used painkiller acetaminophen. Background The advisory committee, known as the Pharmacy Compounding Advisory Committee (PCAC) , was re-created under a piece of 2013 legislation known as the  Drug Quality and Security Act (DQSA) . The law, passed in the wake of a major drug...
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    Should You Pursue a Master's Degree or a Regulatory Affairs Certificate?

    There is mounting evidence that pursuing a professional or graduate certificate may be a very savvy career investment. The popularity of certificates is on the rise. According to a 2012 study from the Georgetown University Center on Education and the Workforce, certificates are the fastest growing postsecondary credential, and second only to bachelor’s degrees in the number earned each year. About 10% of regulatory professionals now have postgraduate certifica...
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    British Regulators Launching Online Registration System for Low-Risk Devices

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The British Medicines and Healthcare products Regulatory Agency (MHRA), responsible for overseeing the UK’s medical device market, is launching a new online registration system for low-risk devices on 11 February 2015. The new  Devices Online Registration System (DORS)  will facilitate online registration of Class I devices, as well as cu...
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    FDA Appoints Members to New, Influential Advisory Committee

    Almost a year after announcing the re-creation of its Pharmacy Compounding Advisory Committee (PCAC), the US Food and Drug Administration (FDA) has announced that it has selected 12 experts who will serve on the influential committee as it considers how best to regulate the pharmaceutical compounding sector. Background The re-creation of the PCAC was called for under the Drug Quality and Security Act (DQSA) , which sought to update the way in which FDA regulated p...
  • FDA Hits Two Compounders for Making J&J Drug That Lacked US Approval

    Two compounding pharmacies are the latest recipients of Warning Letters from the US Food and Drug Administration (FDA), part of a recent surge of letters reflecting the agency's new authority under the Drug Quality and Security Act (DQSA) . Background: Compounding Pharmacies and the DQSA Unlike more traditional pharmaceutical manufacturers-think Pfizer, for example-compounding pharmacies make custom versions of already-approved pharmaceuticals with the stated purpose o...