• Regulatory NewsRegulatory News

    Guest Editorial: Does Nutrition Have a Role in Disease Management?

    This editorial is meant to encourage discussion and thinking about the value of diet and nutrition in the management of disease and a regulatory framework that would be useful in the US to protect public health and provide benefit to individuals who live with chronic disease or an increased risk of such diseases. Introduction The current regulatory approach, with respect to food and nutrition, tends to categorize individuals as consumers or patients and yet these stat...
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    FDA Panel Votes Unanimously in Favor of Gene Therapy to Treat Rare Eye Disorder

    Philadelphia-based Spark Therapeutics took its gene therapy before the US Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Advisory Committee on Thursday and the panel voted 16 to 0 in favor of approving the subretinal injection, representing a major step forward for adeno-associated virus gene therapies. The therapy, known as Luxturna (voretigene neparvovec), has been granted priority review by FDA (the agency has until 12 January 2018 t...
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    Rare Diseases: FDA Awards Grants for 21 Clinical, Natural History Studies

    The US Food and Drug Administration (FDA) on Friday awarded $32 million in research grants to fund 15 clinical studies and six natural history studies for rare diseases. The grants are being funded through FDA's orphan products grants program , with $22 million going to the clinical studies and $9.8 million in combined funding from FDA and the National Center for Advancing Translational Sciences' (NCATS) Therapeutics for Rare and Neglected Diseases program going to fund...
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    FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions

    The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV). In its MDUFA IV commitments, FDA agreed to tighter timelines to reach decisions for most medical device submissions in exchange for increased user fees and the introduction of a n...
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    ICH Plans Work on Clinical Trials Guideline Revision, Pediatric Extrapolation

    The International Council for Harmonisation (ICH) is planning to take up two new topics, according to the minutes released Thursday from the group's meeting in Montreal in May and June. The two topics include the first revision to ICH's 1997 E8 General Considerations for Clinical Trials and a new guideline on pediatric extrapolation in clinical trials, both proposed by the US Food and Drug Administration (FDA). The ICH Assembly also adopted concept papers outlines f...
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    Does FDARA Open the Door to Third-Party Reviews of Implantable Devices? Lawyer Discusses

    Thanks to the new user fee legislation known as the FDA Reauthorization Act (FDARA), the Food, Drugs and Cosmetics Act (FDCA) has been amended to allow for third-party reviews of Class II devices intended to be permanently implantable, life-sustaining or life-supporting. But which devices will be allowed such third-party reviews and what will be the implications? That decision will come from FDA, which has to issue guidance on the topic sometime in the next two ...
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    FDA, HHS Finalize Guidance on Documenting IRB Activities

    The US Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) on Monday finalized a 2015 draft guidance on how to document institutional review board (IRB) activities. The guidance, developed jointly by the two agencies, details how and what IRBs should document in the meeting minutes they are required to keep under 45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2), which include: Attendance at the me...
  • Feature ArticlesFeature Articles

    Conducting a Successful Advertising and Promotion Review of Restricted Medical Devices

    This article provides insight for regulatory professionals regarding developing a successful advertising and promotional review of restricted medical devices. It demonstrates how medical device manufacturers and pharmaceutical companies can improve communication and collaboration between regulatory and marketing to streamline and improve the compliance review process for promotional materials and achieve an effective marketing strategy. The Dance "How small can I make...
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    Generics Industry Calls FDA Draft Guidance on Priority Reviews 'Basically Inoperable'

    A generic drug industry group and several companies have taken issue with recent US Food and Drug Administration (FDA) draft guidance on pre-submission facility correspondence (PFC) that spells out what companies need to do to obtain faster abbreviated new drug application (ANDA) reviews. In June, FDA released the draft guidance noting that it is "critical" for there to be a two-month lead time to determine whether facility inspections will be needed for the 8-mon...
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    FDA to Close Loophole Allowing Companies to Skirt Pediatric Study Requirements

    FDA commissioner Scott Gottlieb announced Tuesday that the agency will release guidance to close a loophole that allows companies to avoid their obligation to study pharmaceuticals in pediatric populations. The situation, according to Gottlieb, arises if sponsors received an orphan designation for a pediatric subtype of an otherwise common and non-orphaned adult disease. For example, with a condition like inflammatory bowel disease (IBD), a drug may be approved to...
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    Drug Reimbursement in Canada

    This article provides a high-level overview of the elements of prescription drug reimbursement in Canada and discusses the costs, processes and reimbursement plans associated with a number of federal health agencies and payers and describes some of the variety of drug plans in place. The Regulatory–Reimbursement Interface Community (out-patient) drug reimbursement is usually considered after a drug has received regulatory approval from Health Canada. Regulatory proces...
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    FDA Reports on FY2016 Pediatric Device Approvals

    In a report to Congress released this week, the US Food and Drug Administration (FDA) says it approved 13 high-risk medical devices for pediatric patients in FY2016, the highest number since 2011 when 15 were approved. Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), device makers are required to include information in premarket approval (PMA) and humanitarian device exemption (HDE) applications about pediatric subpopulations that are affected by ...