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    FDA finalizes instructions for use guidance for drugs, biologics

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on the content and format of Instructions for Use (IFU) labeling for pharmaceutical manufacturers to help consumers understand complicated instructions for using a drug or a biologic.   The guidance covers human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA)....
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    MDR scope extension with human tissue: Regulatory implications and concerns

    Human tissue is newly introduced to the scope of the EU Medical Device Regulation (EU MDR). Although it offers the opportunity for uniform market access of device/tissue products, lack of clarity and borderline challenges remain and are centered on linking a harmonized device framework with a nonharmonized human tissue framework. Concerns include a shortage in the number of available notified bodies, decentralized regulatory oversight for tissues, and absence of an “Articl...
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    European Commission Updates Q&A on Safety Features for Medicinal Products

    The European Commission recently released an updated document setting out nine new and one revised frequently asked questions and answers on the implementation of the rules on the safety features for medicinal products for human use. Building off a previous update in November , five of the new questions deal with general issues, like whether medicinal products can carry more than one batch number, or whether during the transitional period manufacturers located in the E...
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    Industry Proposes Changes to FDA’s FIH Expansion Cohort Guidance

    Industry and oncology groups are calling for changes to the US Food and Drug Administration’s (FDA) recently released draft guidance on first-in-human clinical trials for oncology drugs that feature multiple expansion cohorts.   The 17-page draft guidance, released in August 2018, provides recommendations to sponsors on the design and conduct of such trials, which the agency says can “expedite development by seamlessly proceeding from initial determination of a poten...
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    Successful Human Factors Programs: Key Considerations from a Regulator's Perspective

    This article provides two regulatory leaders insight on human factors engineering considerations for helping manufacturers optimize user interfaces and successfully meet regulatory expectations to bring safe, effective and usable medical devices to market. It was developed from an interview with Shannon Hoste, team lead of the Center for Devices and Radiological Health's (CDRH's) human factors premarket evaluation team and Michael Ryan, acting deputy director in the divi...
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    French Regulators Set Up Dedicated Unit for Overseeing Early Stage Clinical Trials

    France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week announced that it is setting up a new unit dedicated to overseeing first-in-human and other early stage clinical trials. The new unit is part of ANSM's action plan created in response to an incident during a first-in-human trial in France that left one patient dead and five others hospitalized in early 2016. The incident sparked an investigation by ANSM and a led to the Europe...
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    UK’s MHRA Unveils Human Factors Guidance for Medical Devices

    As part of its work to minimize the risks from use error and promote safe practices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released new guidance on human factors and usability engineering for medical device manufacturers. The guidance, intended not just for manufacturers of all device classes and drug-device combination products but notified bodies too, offers a look at the UK’s regulatory framework, comparisons of different ...
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    FDA Finalizes HPV Diagnostic Study Guidance

    The US Food and Drug Administration (FDA) on Thursday finalized its 2015 draft guidance on the types of studies necessary to establish the performance characteristics of diagnostics used to detect human papillomavirus (HPV) when screening for cervical cancer. Background HPV is the leading cause of cervical cancer, with fourteen genotypes of the virus considered to be carcinogenic or high-risk. According to the Centers for Disease Control, cervical cancer was the leading...
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    FDA Finalizes Guidance on Deviation Reporting for HCT/Ps

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance to help manufacturers of non-reproductive human cells, tissues and cellular and tissue-based products (HCT/Ps) understand the agency’s recommendations and relevant examples for complying with the requirements to investigate and report HCT/P deviations. The 20-page guidance, first drafted in December 2015 , includes additional examples and editorial changes to improve clarity from the draft. ...
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    EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research

    The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating that, when alternatives do not exist, the appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for pharmaceutical safety assessments. The opinion is part of a process to reevaluate the same conclusion from 2009 that “recognised that animals s...
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    EMA Revises Guideline on First-in-Human Trials

    The European Medicines Agency (EMA), in cooperation with the European Commission and the EU member states, on Tuesday proposed revisions to its 2007 guideline on first-in-human clinical trials as part of an effort to further improve the safety of participants as trial protocols become increasingly complex. The  revised guideline , which is open for public consultation until 28 February 2017, is intended to further assist sponsors in the transition from non-clinical to ea...
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    FDA Sends Form 483 to Sterile Manufacturer Akorn Pharmaceuticals’ Illinois Plant

    The US Food and Drug Administration (FDA) on Tuesday released a Form 483 (which can be the precursor to a warning letter) with six observations to one of two Akorn Pharmaceuticals’ Decatur, Illinois-based sterile drug manufacturing facilities. The observations were uncovered during a 10-day inspection in June and include quality control issues, unrecorded or unjustified deviations from written production and process control procedures, quality control responsibilities an...