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    EU reference labs: Commission adopts implementing acts

    A new set of implementing acts adopted by the European Commission outlines what EU reference laboratories need to consider in order to serve their customers. The regulations address issues such as how to ensure the labs have proper training and resources to handle workloads as well as how to ensure pricing transparency.   On 17 June, the Commission published two regulations on EU reference labs that may be used by notified bodies and member states to give technical ass...
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    UK’s NIBSC Updates on No-Deal Brexit Plans

    With less than a month remaining before the UK exits the EU, the UK’s National Institute for Biological Standards and Control (NIBSC) on Thursday provided an update in the event of a no-deal Brexit scenario.   In the update, the NIBSC, which produces and distributes a wide range of biological reference materials and functions as the UK’s official medicines control laboratory for biological products, says that while a Brexit deal “remains the Government’s top priority”...
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    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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    FTC Continues Crackdown on Pay-for-Delay Agreements

    The Federal Trade Commission (FTC) on Monday announced several steps taken against Allergan, its subsidiary Watson Laboratories and Endo Pharmaceuticals to fight pay-for-delay settlements between brand-name and generic drug manufacturers that keep generics from entering the US market. According to a complaint filed in the US District Court of Northern California against Allergan, Watson and Endo, FTC is challenging an anticompetitive reverse-payment agreement between En...
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    FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars

    Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is necessary to support a proposed biosimilar. The 18-page guidance is one in a series implementing the Biologics Price Competition and Innovation Act of 2009 (BPCIA) that established a pathway for the approval of such follow-on biologics. Four other final guidance documents and two o...
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    EC Report Calls for New Network of Reference Labs for Human Pathogens

    The European Commission is calling for a formally defined EU-wide system for reference laboratory networks for human pathogens as the benefits are likely to outweigh the costs, according to an analysis of such a system released on Friday. Currently, many national reference labs for human pathogens have a hard time responding in a coordinated manner to new and emerging infectious threats. The aim of an EU-wide network would be to better respond to cross-border threats, a...
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    Generic Drug Labels: FDA Offers Draft Guidance on Updates After Reference Products are Withdrawn

    The US Food and Drug Administration (FDA) on Friday released draft guidance describing the process for drug companies when they have to update a generic’s label after the reference product (for which the generic is based) is withdrawn for reasons other than safety or effectiveness. The guidance focuses on a problem that has long plagued the generic industry, as generic labels are required by law to mirror their reference product counterparts at the time of approval but s...
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    Croatian Regulator Cites Indian Manufacturer for QA, GMP Violations

    The Agency for Medicinal Products and Medical Devices of Croatia (HALMED) on Monday issued a statement of non-compliance to Indian active pharmaceutical ingredient (API) manufacturer Dhanuka Laboratories Ltd. The notice was issued following an inspection of Dhanuka's Gurgaon, India facility conducted on 19 February 2016, during which inspectors discovered 32 good manufacturing practice (GMP) violations, including one critical violation involving Dhanuka's "weak" quality ...
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    Updated: FDA Warns Banned Indian API Manufacturer Over Filth, Incomplete Complaint Records

    Mumbai-based active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories is quickly turning into the poster child for how to run afoul of nearly every major pharmaceutical regulator. This week, the US Food and Drug Administration (FDA) released its warning letter for the company following an eight-day inspection in March 2015. The three major issues uncovered by FDA included the company’s failure to record or investigate quality-related customer compla...
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    EMA Assesses Concerns With Indian Generic Firm’s Clinical Data

    The European Medicines Agency (EMA) has begun a review of medicines for which studies have been conducted at Alkem Laboratories’s site in Taloja, India due to data integrity concerns. The review follows a joint good clinical practice (GCP) inspection of this site by German and Dutch regulators in March 2015, which raised issues with study data used to support the marketing authorization applications of some medicines in the EU. Following consideration of the inspectio...
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    FDA Releases Long-Awaited Draft Guidance on Biosimilar Labeling

    The US Food and Drug Administration (FDA) on Thursday unveiled draft guidance on biosimilar labels, which will rely heavily on their reference products’ labels, though the biologics industry will likely be happy that the labels must make certain clarifications about the biosimilar and reference product. At the outset of the 15-page guidance, FDA makes clear that biosimilar product labeling should not include a description of a clinical study that merely supports a demons...
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    FDA Warns Indian Drugmaker Over Major Data Integrity Violations at Three Plants

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter to India-based Ipca Laboratories after inspections at three of its manufacturing facilities revealed data integrity violations. All three of the plants are already banned from sending products to the US. The warning letter, dated 29 January, reveals how inspectors found “systemic data manipulation” at Ipca’s Ratlam facility in Madhya Pradesh, “including actions taken by multiple analysts, on...