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    Public Availability of Expanded Access Policy: how to Comply With new Requirements

    This article discusses the process for complying with expanded access policy requirements. Introduction The unexpected passage of the 21st Century Cures Act (the act) in December 2016 has become in terms of job security for the Regulatory Intelligence (RI) professional, a gift that keeps on giving. Many companies, even now, continue to grapple with analysis, planning, integration and compliance with various policy and regulatory components of the 966-page piece of leg...
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    Re-Designing Regulatory Capabilities

    Faced with growing regulatory burdens, Bristol Myers Squibb (BMS) and Halozyme each committed time and resources to connect regulatory functions from end-to-end with the goal of improving efficiency and transparency. This article describes how two very different companies made their business case, streamlined processes and managed change. The article also provides elements of what the two companies learned along the way. Introduction Life sciences companies are driving ...
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    US Orphan Drug Legislation: Current Status and Recent Developments

    This article discusses the impact of recent orphan drug legislation and regulatory developments and covers the Food and Drug Administration Reauthorization Act of 2017 (FDARA), the Orphan Drug Modernization Plan and the 21st Century Cures Act. The authors answer questions regarding what drugs qualify as an orphan drug and how an orphan drug gets approval. Introduction While they have had legal existence for close to 35 years and often served as a regulatory strategy for...
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    Regulatory Operations, Resources and eCTD Benefits

    Articles posted throughout March included in-depth coverage on the use of electronic Common Technical Documents (eCTDS), regulatory resources and operations, FDA's citizen petition process and ASEAN harmonization efforts. eCTD Update The deadline after which all Investigational New Drug Applications (INDs), Drug Master Files (DMFs) and their amendments will be required to be both in Common Technical Document (CTD) format and submitted electronically (collectively called...
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    eCTD: A Global Regulatory Overview

    This article outlines the global status of electronic Common Technical Document (eCTD) and its implementation impact on companies. The author provides an international overview and focuses on regulatory eCTD submission requirements and global harmonization for medicinal products for human use in Canada, Europe, Japan and the US. Tips for organizing common technical documents are included. Introduction The electronic Common Technical Document (eCTD) is an international s...
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    Budgeting for the IND in an eCTD Format: to Insource or Outsource?

    This article explains a process for converting from paper-based Investigational New Drug (IND) applications and Drug Master Files (DMF) to submitting IND/DMFs in an electronic Common Technical Document (eCTD) format. To comply with the approaching deadline, the authors offer tips on how to make a smooth conversion and discuss the relative merits of in-house work versus outsourcing. They also present information for estimating the costs of outsourcing. Introduction As th...
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    Electronic Publishing Conversion: A Reference Guide to Converting Paper Submission to eCTD

    This article provides a reference guide to help regulatory professionals navigate the electronic Common Technical Document (eCTD) steps necessary for successful compliance. Introduction The 5 May 2018 deadline, after which all commercial Investigational New Drug Applications (INDs), Drug Master Files (DMFs) and their amendments will be required to be both in Common Technical Document (CTD) format and submitted electronically (collectively called the eCTD), is fast-appro...
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    Current Regulatory Harmonization Efforts in ASEAN Countries

    This article describes efforts at creating pharmaceutical regulatory harmonization in Southeast Asia spear-headed by the Association of Southeast Asian Nations (ASEAN). The author discusses current barriers and issues representing challenges to harmonization, such as different strategies and social and cultural realities among the 10-member nations participating in ASEAN. Efforts at harmonization conducted by ASEAN's Pharmaceutical Products Working Group developing a pan-...
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    Regulatory Operations: Leveraging eCTD Benefits

    This article discusses the growing requirement by health agencies for electronic Common Technical Document (eCTD) submissions rather than paper applications and explores how this move can be beneficial for organizations. Introduction Around the world, the electronic Common Technical Document (eCTD) is becoming the mandated submission format for drug applications. The US Food and Drug Administration (FDA), the European Medical Agency (EMA), Health Canada and Swissmedic a...
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    FDA Citizen Petitions: What They Can and Cannot Do

    This article provides an overview of the US Food and Drug Administration's (FDA's) citizen petition process as it relates to the drug industry and highlights several key issues raised by this process. The authors focus on 505(q) and discuss its potential implications. Introduction FDA regulations provide for a citizen petition process enabling the public to request FDA to take or refrain from taking a certain action. The citizen petition process also is used to bring ot...
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    Regional eCTD Validation and Acceptance Criteria: Comparing FDA, Health Canada and EU Requirements

    This article examines regulatory requirements established by agencies in the US, Canada and European Union and describes how the electronic Common Technical Document (eCTD) standard has been changing to support this evolution. 1 Introduction The electronic Common Technical Document (eCTD) as a standard of transfer of regulatory information from industry to agency was signed by the International Conference on Harmonization of Technical Requirements for Registration of P...
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    eCTD Transition: Preparing for a Compliant Submission

    The electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements and reports to FDA's Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) for investigational new drug applications and drug master files. FDA's mandatory transitioning deadline for eCTD compliance is 5 May 2018. This article discusses what companies need to know to prepare a compliant submission under...