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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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    Regulatory Intelligence: 2017 FDA Review and Trends to Watch

    This article provides a variety of websites with important information on recent changes to FDA guidances and tables showing user fees, new provisions, and impact analyses. It also reviews trends and recently passed acts and provides website tools for keeping abreast of changes under the new administration. Introduction Sometimes a year will go by and the regulatory process will seem to move in geologic time (eons versus real time) and nothing new has happened. That was...
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    The Prescription Drug User Fee Act (PDUFA): A Primer

    This article discusses key points and benefits of the Prescription Drug User Fee Act (PDUFA) for those filing a New Drug Application (NDA) and explains how PDUFA user fees have played an important role in expediting FDA's drug approval process. Introduction: Benefits Offered by PDUFA When planning a New Drug Application (NDA) or other type of marketing application, regulatory professionals must consider many things. These considerations include: when the data will com...
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    2017 Regulatory Intelligence Tools Update: Drugs

    When tasked with something new or different in regulatory, sometimes the hardest challenge is knowing where to find the information. This article provides an abundance of tools, links and places to start your journey of regulatory information discovery. Regulatory intelligenceis "the act of gathering and analyzing publicly available regulatory information." This includes communicating the implications of that information and monitoring the current regulatory environmen...
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    Regulatory Intelligence Tools Compendium 2017

    This article provides a Regulatory Intelligence (RI) Tool Compendium to help readers see the tools available by each RI functional area. "I don't need to know everything, I just need to know where to find it, when I need it." Albert Einstein In the recently updated, second edition of " Regulatory Intelligence 101 ," a new chapter was added about how to measure RI output, which can be difficult to quantify and how RI supports the due diligence effort. After working...
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    Book Review: The FDA Clinical Submission Survival Manual

    A regulatory professional's primary role is communication with FDA, other regulatory agencies and internal stakeholders in the written and oral form. The quality of a regulatory professional's communication skills can make or break a company. " The FDA Clinical Submission Survival Manual " contains useful tips and processes to improve FDA communication. It contains specifics on how to plan, develop and test strategy and key messages for a marketing application, with a fo...
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    Scientific Advice Meetings With Health Canada

    Types of Meetings With Health Canada Meetings with Health Canada are similar to US Food and Drug Administration (FDA) meetings or Scientific Advice meetings with either the European Medicines Agency (EMA) or individual EU Member States. A meeting request is submitted with questions to provide some background to introduce the agency to the company’s development program and establish why the meeting is needed. Once a meeting date has been set, the company sends a meeting p...
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    21 CFR Part 11: The Ins and Outs of One of FDA's Most Difficult Rules

    Introduction 1992 was a different time, when the Internet was still in its infancy and email as a corporate tool was only just beginning to take hold. In the life science industry, there were dreams—then unrealized—of a completely electronic and totally paperless office. And at the US Food and Drug Administration (FDA), regulators were only just beginning to realize the potential effects digital data management systems could have on product development. It was around th...
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    Orphan Drugs Around the World: The Regulations and Requirements You Need to Know

    "Orphan drugs" are product intended for use in the treatment of a "rare" disease—those diseases that occur infrequently or rarely in the general population of a specific location.  Rare diseases affect a limited number of people out of the whole population, and the definition varies on a country-by-country basis; it is country-specific and population-dependent.  It is estimated that between 5,000 and 8,000 (typically averaged to 7,000) distinct rare diseases exist today,...
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    Book Review: Targeted Regulatory Writing Techniques

    Medical writing and regulatory greatly rely on and closely relate to each other. Some professionals start out as medical writers and cross over to regulatory writing or vice versa. In small companies, the regulatory professional often does much of the medical writing. It often is hard to enter either field expecting to be trained on "the basics," since those vary by company, corporate culture, opportunities to learn and co-workers' experience and willingness to mentor. T...
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    Regulatory Information and Intelligence Tools: Devices

    It is important to have the right tools and resources for information about medical device regulations. The tables in this article offer a quick listing of pertinent information online that can be accessed at any time. We will take you on a tour of discussion groups, blogs, journals, newsletters, education services, regulatory informational databases, professional and trade organizations, regulatory affairs service providers and sites to visit, many of which includea lot...