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    FDA Cites Korean Manufacturer Over Unapproved Device

    In a recent untitled letter to South Korea-based Ycellbio Medical, the US Food and Drug Administration (FDA) warned of potential violations against medical device regulations.   FDA’s review of the manufacturer’s website found its Y-PRP system falls under the FD&C Act’s definition of a medical device. For example, the website states the Y-PRP system “facilitates separating and harvesting ‘pure sources of concentrated platelets’ without much skill.”   But the ...
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    IPRP Details Expectations for Biodistribution Assessments for Gene Therapies

    The newly formed International Pharmaceutical Regulators Programme (IPRP) has released a reflection paper laying out expectations for non-clinical biodistribution (BD) assessments for gene therapies (GT).  The reflection paper was developed by the international body's Gene Therapy Working Group (GTWG) in April and approved by the IPRP Management Committee at its  first-ever meeting  last month.  BD assessments are conducted to determine the distribution, persistence and...
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    FDA Credits Pilots for Three-Week Review of New Kisqali Indication

    The US Food and Drug Administration (FDA) on Wednesday approved a new indication for Novartis' targeted breast cancer drug Kisqali (ribociclib) after reviewing the drug under two new pilot programs aimed at improving the efficiency of oncology drug submissions and evaluations.  Using the two programs, FDA says it was able to approve the new indication for the drug less than a month after its formal submission on 28 June 2018.  "With this approval, we've demonstrated som...
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    Form 483 for Akorn’s Illinois Site Rekindles Questions on Fresenius Buyout

    Back in late February, Fresenius and Akorn traded barbs over whether Akorn breached US Food and Drug Administration (FDA) data integrity requirements that threatened the German drugmaker's $4.3 billion purchase of the US generics maker. Then in March details on why Fresenius sought to terminate its acquisition of Akorn emerged, with Fresenius alleging a top executive at Akorn had knowingly submitted fabricated data to FDA, and Fresenius pulled out of the deal in April...
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    FDA Drafts 26 New Product Specific Guidances for Generic Drugmakers

    The batch of new and revised US Food and Drug Administration (FDA) guidance features 43 product-specific guidances, including 26 new guidances and 17 revised guidances that, when finalized, will describe FDA’s expectations on how to develop generic drugs that are therapeutically equivalent to their respective reference-listed drugs. Ten of the new draft guidance documents and six of the revised guidances are for complex drug products: an area that’s been a focus for FDA...
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    FDA to Develop Importation Policy for Sole-Source Drugs

    At the direction of Department Health and Human Services (HHS) Secretary Alex Azar, the US Food and Drug Administration (FDA) on Thursday announced it will work to develop a policy to facilitate the importation of certain sole-source drugs in response to dramatic price hikes and supply disruptions. The policy is an attempt to head off the tactic employed by Martin Shkreli and Turing Pharmaceuticals in 2015 when it acquired the off-patent drug Daraprim (pyrimethamine), t...
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    Interchangeable Biosimilars: The Central Path to Lower Biologic Prices?

    With the first interchangeable biosimilars expected to come to market by 2020, anticipation has heightened on what kind of impact these products will have, particularly when competing with other non-interchangeable products.   But before that first advisory committee is announced, speculation has swirled on whether doctors will be prepared to understand the concept of interchangeability (what with the discussion on substitution and switching studies, and the lack of in...
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    Field Alert Report Submissions: FDA Offers Draft Q&A

    The US Food and Drug Administration (FDA) on Wednesday issued draft guidance providing the agency’s current thinking on the requirements for submitting field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Specifically, an NDA or ANDA applicant must submit a FAR to FDA within three working days of receiving the following kinds of information for distributed drug product(s): “(i) Information concerning ...
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    EU Regulatory Roundup: EMA Finalizes Guideline on Gene Therapies

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   UK Pauses Use of Vaginal Mesh After Independent Review Posts Early Findings   The United Kingdom has temporarily stopped using vaginally inserted surgical mesh to treat stress urinary incontinence. Officials instigated the hiatus on the recommendation of an independent group the government formed to review how the UK handles adverse events linked to drugs and medical...
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    FDA’s CDER Unveils Details of Reorganization

    The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) on Thursday announced the details of a major reorganization, affecting nearly one-third of CDER.   The proposed reorganization will impact the Office of New Drugs, Office of Compliance, Office of Executive Programs, and Office of Communications and has been submitted to HHS, though still must be approved by HHS and submitted to Congress for concurrence. The changes will be in effect on...
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    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 19 July 2018 to include: Novartis plans to use one of its two PRVs. SIGA Techn...
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    FDA Adopts ICH Addendum on Multiregional Clinical Trials

    The US Food and Drug Administration on Wednesday adopted an addendum to the International Council for Harmonization's (ICH) guidance aimed at supporting drug sponsors in the collection of data from multiregional clinical trials (MRCTs).  The guidelines in E17 General Principles for Planning and Design of Multi-Regional Clinical Trials detail seven “basic principles” to follow when designing MRCTs.  Identified principles include “prespecified pooling of regions or subp...