• Regulatory NewsRegulatory News

    EMA Offers New Guidance on Type II Variations and MA Extensions of Orphan Drugs

    The European Medicines Agency (EMA) has updated its post-authorization guidance on how extensions of marketing authorizations and type II variations may impact orphan-designated medicines. The updates follow the publication of a new  notice by the European Commission on the application of Articles 3, 5 and 7 of Regulation (EC) No. 141/2000 on orphan medicinal products . In this notice, the European Commission provides guidance on the application of the Orphan Regulation,...
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    FDA Officials Share Best Practices for Biosimilar Development

    With industry interest in biosimilars continuing to grow, top officials at the US Food and Drug Administration (FDA) are urging sponsors to leverage agency advice and follow best practices to ensure the timely success of their biosimilar development programs. The regulators' advice comes as the agency and industry prepare for the next era of FDA's biosimilars program under the second Biosimilar User Fee Act (BsUFA II) . According to Leah Christl, associate director f...
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    EMA Sets Deadlines for 2016 Type I Variations

    The European Medicines Agency (EMA) on Monday said that marketing authorization holders (MAHs) need to submit any minor changes to drug marketing authorizations, also known as Type IA IN and Type IA variations, for 2016 by 30 November. MAHs are also advised to submit any Type IB variations or groupings of Type IB and Type IA variations in 2016 by 13 December 2016. The deadlines have been set so that EMA can acknowledge the validity of the submissions before the age...
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    Updated: GDUFA II Performance Goals: 8-Month Priority Reviews, More Timely Correspondence

    The US Food and Drug Administration (FDA) will speed the review of abbreviated new drug applications (ANDAs) and work with generic drugmakers on a closer and more timely basis, according to the draft performance goals and program enhancements for the Generic Drug User Fee Act (GDUFA) reauthorization for FYs 2018-2022, known as GDUFA II. The GDUFA II performance goals letter, released last Friday, follows more than a year of negotiations between FDA and the...
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    FDA Extends UDI Compliance for Certain Class II Devices

    The US Food and Drug Administration (FDA) is giving medical device labelers two more years to comply with unique device identifier (UDI) requirements for certain Class II devices. In a letter to device labelers dated Tuesday, FDA said it is extending the UDI compliance dates for so-called device convenience kits and repackaged single-use devices and is clarifying the compliance date for device constituents for certain combination products. Under the UDI rule, FDA establ...
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    Biosimilar User Fees: FDA and Industry Reach Agreement

    The US Food and Drug Administration (FDA) and representatives of the biotechnology industry have reached an agreement on the second iteration of the Biosimilar User Fee Act (BsUFA II) following 14 meetings from March through May. Specifically, the two sides have settled on the draft commitment letter that represents the agreements made over the course of the negotiations, which initially began in December 2015. Similar to FDA's other user fee programs, BsUFA is a ...
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    GDUFA Reauthorization: GPhA and Catalent Make Specific Requests

    As the US Food and Drug Administration (FDA), industry and other stakeholders continue to meet and discuss what provisions the next iteration of the Generic Drug User Fee Act (GDUFA) should contain in 2017, both the Generic Pharmaceutical Association (GPhA) and contract manufacturer Catalent, among others, have outlined particular requests. Since 2012, when the first $1.5 billion GDUFA program was created to provide FDA with industry funds to ensure a more consiste...
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    FDA: Some Type 2 Diabetes Drugs May Increase Risk of Heart Failure

    The US Food and Drug Administration (FDA) on Tuesday updated its safety communication for Type 2 diabetes medicines containing saxagliptin and alogliptin as they may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. FDA has added new warnings to the following drug labels about this safety issue: AstraZeneca’s Onglyza (saxagliptin) AstraZeneca’s Kombiglyze XR (saxagliptin and metformin extended release) Takeda’...
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    API DMFs for ANDAs: FDA Finalizes Guidance on Completeness Assessments

    The US Food and Drug Administration (FDA)'s final guidance issued on Friday will help the generic drug industry prepare for completeness assessments for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA). The guidance, first released in draft form in 2012 , lays out requirements for how companies will have to pay a DMF fee, which for FY 2016 is $42,170, when fi...
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    Dramatic Drop in Hydrocodone Combo Prescriptions After DEA Rescheduling

    Prescriptions for hydrocodone combination products (HCPs) fell significantly after the US Drug Enforcement Agency (DEA) tightened restrictions on those drugs, according to a study published Monday in JAMA Internal Medicine . For years the US has been in the grips of a prescription drug abuse epidemic, in part driven by the availability of hydrocodone and other opioids such as oxycodone, codeine and methadone. In 2013, more than 200 million prescriptions for opioids we...
  • Feature ArticlesFeature Articles

    Creating Type IA and Type IB Variation Submissions in Europe

    This article discusses the creation of minor variations within the European Union. Change is constant in the business world. Change, managed correctly enables continuous improvement, a key element of the regulatory compliance systems governing the pharmaceutical industry. Changes need to be assessed in regard to whether they need to be reported to the regulatory agencies, as it may change the information held by the authorities. As part of the marketing application pr...
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    Researchers Question Consistency of FDA’s Use of Surrogate Endpoints for Drug Approvals

    The US Food and Drug Administration (FDA) is not consistent with its use of surrogate endpoints in assessing the risks and benefits of treatments for some diseases, making it difficult to assess the treatments' actual clinical effects on outcomes important to patients, according to researchers from Johns Hopkins. The researchers came to this conclusion after evaluating 58 FDA drugs approved between 2003 and 2012 for chronic obstructive pulmonary disease (COPD), Type 1 an...