• FDA Sets New Priorities for Foods and Veterinary Medicine

    17 July, 2012 News Desk, Food Safety News

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • The U.S. Biosimilar Pathway Nearly Three Years Later

    11 December, 2012 Erika Lietzan and Laura Sim, Covington & Burling LLP

    Note: The views expressed in this article are those of the authors and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • Trends in Q1 Warning Letters

    30 October, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    If you work in the life science industry, it is always a good habit to periodically check the FDA's website for enforcement actions and warning letters. You can glean important insights from the mistakes and weaknesses of other companies in your industry, maybe even your competitors. You will see what the FDA is emphasizing in inspections, perhaps see some trends.

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  • Surviving the Back Room During an FDA Inspection

    17 July, 2012 Christine Park, Christine Park & Associates

    During one of my early inspection experiences with the FDA, I found myself working with a team that felt it didn't need a backroom setup to review documents prior to bringing them to the investigator. Naively, I agreed to let the team move forward with the inspection. As the observer, I watched as things spiraled out of control.

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  • Process Verification vs. Process Validation: What You Need to Know

    10 May, 2012 Andrew Snow, Momentum Solutions, LLC and Walt Murray, MasterControl, Inc.

    Note: The views expressed in this article are those of the authors and do not necessarily represent those of their respective employers, GxP Lifeline, its editor or MasterControl, Inc.

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  • What Does a New FDA Quality Office Mean?

    14 August, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    The news that the FDA is creating a new Office of Pharmaceutical Quality probably set off the alarm bell for the industry. Does a new quality office mean new requirements? It’s the first question that comes to mind.

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  • The Importance of Computer Systems I/Os Accuracy Checks

    5 June, 2012 Orlando Lopez, Independent Consultant

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • How to Prepare your Design History File (DHF) for an FDA Inspection

    10 August, 2013 Robert Packard, Regulatory Consultant, MedicalDeviceAcademy.com

    FDA inspections strike fear into most companies, but most of the fear is due to a lack of knowledge about what to expect from the FDA. Therefore, the person responsible for the design control process at your company should read two important documents—in addition to this article:

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  • FDA User Fees: What Have They Done for You Lately?

    28 November, 2012 Marla Scarola, M.S., RAC, Senior Consultant, The Weinberg Group Inc.

    The U.S. Food and Drug Administration (FDA) user fees have been a fact of life for regulated industry for nearly two decades. Over the past 20 years, the Prescription Drug User Fee Act (PDUFA) has allowed FDA to speed up review times for new drug applications (NDAs) and biologic license applications (BLAs), ultimately decreasing the amount of time it takes drugs and biologics to reach the market.

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  • FDASIA: Key Statutory Changes for Medical Device Companies

    29 January, 2013 Pamela F. Forrest, Elaine H. Tseng and Steven Niedelman, King & Spaldings FDA/Life Sciences Practice Group

    The Food and Drug Administration Safety and Innovation Act (FDASIA), enacted July 9, 2012, is the most recent statute impacting FDA's regulation of medical devices. FDASIA is significant not only because it reauthorizes user fees for device submissions, in exchange for FDA's commitment to achieve certain performance goals in the review of those submissions, but also because it institutes various other changes to the device regulatory framework. Several of these should or may benefit medical d

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  • FDA Says Part 11 Guidance Remains Status Quo

    4 May, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    Time and again, rumors surface about the possible update of the 2003 guidance on the scope and application of 21 CFR Part 11. The never-ending speculation attests to the enduring interest in Part 11, not to mention the continued scrutiny of the regulation.

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  • FDA Issues Draft Guidance on Biosimilar Product Development

    22 March, 2012 PharmaManufacturing.com

    The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • FDA Fields Tough Questions About Inspections

    30 August, 2012 Agnes Shanley, Editor in Chief, PharmaManufacturing.com

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • FDA Compliance Officer: Industry, FDA Must Focus on Device Quality (Not Just Compliance)

    28 November, 2012 Arundhati Parmar, www.medcitynews.com

    Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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  • Is FDA to Blame for Biomedical Industry's Slow Growth

    31 January, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    Given the global economic challenges today, it is understandable that the biomedical industry sees lack of funding as a key obstacle in growth. What is surprising is that the industry also sees the FDA and the current regulatory environment as a stumbling block.

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  • FDA Compliance Software

    18 April, 2017 MasterControl

    Companies competing within the rigorous FDA regulated environments know how important attaining and sustaining compliance is to yearly success which can be easily achieved through MasterControl's FDA compliance software. MasterControl Inc. is a leading provider of FDA compliance software, helping hundreds of life science companies around the world realizes their EU regulatory and FDA compliance goals. Our quality management system meets all FDA 21 CFR Part 11 regulations.

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  • Creating, Staffing and Managing an Inspection War Room

    4 May, 2013 Walt Murray, Director of Quality and Compliance Services, MasterControl Inc.

    When I served in the military there was a term used that is still pretty familiar today: "sound general quarters!" When this order was issued, everyone instinctively stopped what they were doing and manned whatever station was theirs during that time. All commands during general quarters came from the war room behind the bridge of the vessel.

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  • Challenges in Combination Product Regulation

    17 July, 2012 Mark D. Kramer, President, Regulatory Strategies, Inc.

    Combination products raise a variety of regulatory challenges. In addition to the unique technological and scientific challenges these products may raise, when drugs and devices, drugs and biologics or devices and biologics are combined to create a new product, consideration must be given to what regulatory requirements will apply to the combination product as a whole. This article explains the key principles and processes established for the assignment, premarket review, and postmarket regula

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  • Ten Points for Successfully Addressing Warning Letters

    10 July, 2013 By Maria Fagan, President, Regulatory & Quality Solutions LLC

    Each year, the FDA issues hundreds of warning letters to medical device companies for reasons ranging from manufacturing practice violations to breaches in labeling and misbranding. Companies responding well to the FDA’s demand for prompt compliance will ultimately return to the agency’s good graces and through the experience develop processes that result in better business, both culturally and financially. But getting to that point may be a slippery slope if the issues in the letter are not

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