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    Association Calls on FDA to Regulate Online Vision Exam as Medical Device

    The American Optometric Association (AOA) has submitted a complaint to the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) over an online eye exam that may not accurately generate prescriptions for eyeglasses or contact lenses. The complaint is directed at Opternative , which is marketing its online eye exam directly to consumers and claiming that it can provide a prescription for eyeglasses or contact lenses “as accurate as an i...
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    Counterfeit Versions of Gilead’s Blockbuster Hepatitis C Drug Found in Israel

    Counterfeits of Gilead’s mega-blockbuster hepatitis C treatment Harvoni, which is generating billions per quarter in sales for the company, are emerging in Israel. Switzerland’s drug regulator Swissmedic said over the weekend that the plastic bottles of the counterfeits, which originated in India, were imported via a Swiss trading company and “contain white instead of genuine yellow film-coated tablets,” the regulator said. Swissmedic is working with other EU authoritie...
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    MHRA Takes Action on LinkedIn Pharma Marketing

    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Friday said it has reprimanded the dermatology company Galderma after receiving an anonymous complaint about promotional material for a prescription drug shared on the social networking site LinkedIn. MHRA said it upheld the complaint as the UK, unlike the US, does not allow prescription-only medicines to be promoted to the public though it does allow advertisements for over-the-counter medicines, accor...
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    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products can safely and effectively exchange data, the US Food and Drug Administration (FDA) on Monday released new draft guidance on how to design such interoperable devices, as well as recommendations for labeling.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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    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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    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...
  • FDA Program to Loosen Import Restrictions for 13 Major Pharmaceutical Manufacturers

    Thirteen of the US' most prominent pharmaceutical manufacturers will be allowed to import their products into the US with less regulatory scrutiny under a pilot program set to begin this year, the US Food and Drug Administration (FDA) has announced. Background FDA first announced the pilot program, known as the Secure Supply Chain Pilot Program (SSCPP) in January 2009 with that stated intent of better securing finished pharmaceutical products and their raw active ingred...