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    CGT Designations: FDA Explains Process in New Draft Guidance

    The US Food and Drug Administration (FDA) on Friday released draft guidance providing information on how sponsors can apply for competitive generic therapy (CGT) designation and when they may be eligible for CGT exclusivity. The CGT designation, which was established with the  FDA Reauthorization Act of 2017 (FDARA), is meant as an incentive for industry to develop generics for drugs lacking competition. To date, FDA has granted more than 100 CGT designation reque...
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    Tropical Disease PRV Fix Didn’t Stop Novartis From Winning Another

    Back in 2017, a new law was enacted, known as the FDA Reauthorization Act (FDARA), which contained not only the new user fee programs for pharmaceuticals, medical devices, generics and biosimilars, but also a slight tweak to the tropical disease priority review voucher (PRV) program. The change was meant to ensure that companies winning PRVs actually performed some of the clinical work to bring the tropical disease drug to market in the US, and that the drugs “were ...
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    CDER Plots Established Conditions Pilot

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Thursday announced a new pilot program where sponsors can propose explicit established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or as a prior approval supplement (PAS). Building off a draft guidance issued in 2015 on ECs and reportable chemistry, manufacturing, and controls...
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    Drugmakers Debate Whether Parts of FDA’s Biosimilar Guidance are Unconstitutional

    Drugmakers and trade groups have raised questions with two US Food and Drug Administration (FDA) guidance documents on biosimilars, including one explaining how FDA plans to transfer drugs previously approved under new drug applications (NDAs) to be biologic license applications (BLAs). On this so-called “Deemed to be a License” guidance , which explains the NDA to BLA transition, all but one of the biopharma companies and industry groups took issue with the agency’s a...
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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 13 February 2019 to include: Novartis wins a PRV as FDA approved Egaten (tricla...
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    CDER Proposes Program to Create Voluntary Pharmaceutical Quality Standards

    With an aim to promote innovation in pharmaceutical development and manufacturing, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Wednesday released draft guidance to begin the process of creating a program on voluntary consensus standards related to pharmaceutical quality. Although the 7-page draft guidance does not offer examples of what such standards would look like, it does describe how the use of a recognized standard...
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    FDA Updates List of Brand Name Companies Blocking Generic Applicants

    Back in November 2017, FDA Commissioner Scott Gottlieb called on brand name drug companies to “end the shenanigans” around delaying or restricting generic drug competition. But that call to action has not stopped brand name companies from continuing to pursue at least one gaming tactic, which is refusing to provide samples to competitors looking to bring generic products to market. As part of an effort to deter such a tactic, FDA recently created and updated a list o...
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    WHO Warns of Falsified Versions of Cancer Drug Iclusig

    The World Health Organization is warning regulators, industry and health care professionals to be on the lookout for falsified versions of Takeda and Incyte’s leukemia drug Iclusig (ponatinib). The announcement comes as on 15 January, WHO was informed by health authorities in Switzerland that a local wholesaler had purchased packs of the 15mg version of Iclusig and upon verification, the market authorization holder confirmed the packs as falsified. Further investigation...
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    FDA Warns McKesson for Distributing Illegitimate Products

    In its first warning letter issued under the Drug Supply Chain Security Act (DSCSA) ,  the US Food and Drug Administration (FDA) on Tuesday detailed how San Francisco-based McKesson distributed illegitimate drugs to pharmacies. In September and October 2016, McKesson was notified that three separate Rite Aid pharmacies in Michigan received illegitimate product, which had been distributed by McKesson. “The seal of the bottle was broken, and the bottle contained no o...
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    EU Looks to Craft Harmonized Definition of a Drug Shortage

    Part of what’s holding back a more concerted European-wide push to combat and manage drug shortages is a harmonized definition for a shortage, according to a report released Monday on a November meeting discussing the availability of authorized medicines. “The lack of a European-wide definition for shortages has long been a factor hampering a harmonised European-wide approach to managing shortages,” the report says. Annette Byrholt Hansen from the Danish medicines Ag...
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    CERSI Collaborations With FDA: Priority Research

    Since 2012, the US Food and Drug Administration (FDA) has engaged with universities across the country on dedicated research projects targeting the agency’s public health priorities. Frank Weichold of FDA’s Office of the Chief Scientist recently explained in Clinical Pharmacology & Therapeutics how the work at the four Centers for Regulatory Science and Innovation (CERSI) supported by cooperative agreement grants from FDA is going. The four CERSIs currently are the Un...
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    Poland, Slovenia Added to GMP Agreement Between US and EU

    Earlier this month, the US Food and Drug Administration (FDA) confirmed the capabilities of Poland and Slovenia to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. FDA can now rely on a total of 22 member states to replace their own inspections, although the European Medicines Agency (EMA) notes that imported products still need to be batch tested until FDA recognizes all EU member states' authorities for human pharmaceuticals. ...