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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    The US Food and Drug Administration (FDA) on Wednesday issued draft guidance providing the agency’s current thinking on the requirements for submitting field alert reports (FARs) by applicants of new drug applications (NDAs) and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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    Gottlieb Assesses Slow Biosimilar Uptake in US, Offers a Plan to Instigate Competition

    FDA Commissioner Scott Gottlieb unveiled the agency’s 11-part biosimilar action plan at the Brookings Institution on Wednesday, explaining the “anemic” growth the market has seen so far.   “I’m worried that the market for these products still isn’t established,” Gottlieb said, noting 11 biosimilars have been approved but just three have gained market share. “The ability for these products to penetrate clinical practice, and gain acceptance, is still not firm.”   As...
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    UK Votes to Stay in EMA

    The UK Parliament on Tuesday voted 305-301 in favor of continuing the UK’s involvement with the European Medicines Agency (EMA) after the island leaves the EU. The vote means Parliament will make it a negotiating objective for the UK government to seek the UK's participation in the European medicines regulatory network, according to the UK BioIndustry Association (BIA). In a joint statement on behalf of the pharmaceutical industry in the UK, Mike Thompson, chief exec...
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    FDA’s OGD Director to Retire in February

    After 20 years of service at FDA, Kathleen “Cook” Uhl, director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD), will retire in February 2019. Center for Drug Evaluation and Research Director Janet Woodcock said in an email to staff: “Though we are sad to see Cook leave CDER, she leaves in place a stronger generics program and an outstanding leadership team.” Cook joined FDA in 1998 as a CDER medical officer in clinical pharmacology. She ...
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    FDA Warns Claris Injectables Manufacturing Site

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 5 July to a Baxter-owned manufacturing site following a nine-day inspection last July and August. In two instances, the Claris Injectables Ahmedabad, India-based site acquired by Baxter (as part of a more than $600 million acquisition that closed in July 2017) was found to have invalidated out-of-specification (OOS) results without adequate investigation and scientific justification. ...
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    Breakthrough Designation: Pivotal Trials Lack Randomization, Double-Blinding and Control Groups

    A review of all therapeutics receiving a breakthrough designation and approved from 2012 to 2017 found a lack of randomization, double-blinding and control groups in pivotal trials supporting approval, a research letter published Tuesday in JAMA found.   The research letter , written by Jeremy Puthumana, Joshua Wallach and Joseph Ross of Yale University, also revealed the use of surrogate endpoints in such pivotal trials and smaller trials too. However, of the 46 th...
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    AdvaMed Raises Questions With FDA’s Combo Product Proposed Rule

    AdvaMed is taking issue with the US Food and Drug Administration’s product jurisdiction proposed rule, which the device group thinks strays from how the 21 st Century Cures Act defined combination products, according to comments released Monday. Some of the proposed revisions run counter to the plain language and intent of Section 3038 of the Cures Act , AdvaMed said. The group is seeking to clarify that a combination product’s primary mode of action shall not be de...
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    EMA Report: Clinical Data Published on 50 Medicines in One Year

    The European Medicines Agency (EMA) on Monday published its first report on implementing its policy on the publication of clinical data whereby researchers, academics and others can access data from clinical reports submitted by pharmaceutical companies to EMA for new medicines as of 1 January 2015. The 27-page  report  covers one year from the launch of EMA’s  clinical data website  on 20 October 2016, and lists the 50 medicines for which clinical data were published, ...