• FD&C Amendments at Work in the Pharmaceutical Industry - Are They Working for Your Company?

    18 April, 2017 Marci Crane

    The FD&C (Food, Drug and Cosmetic) Act, initially passed in 1938, has greatly influenced, and continues to influence, the ebb and flow of the pharmaceutical industry. The FDA also plays a big part in that influence since it is common for the FDA to interpret the Act for executive purposes.

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  • At the Heart of Clinical Research: The Protocol

    18 April, 2017 Rebecca Daniels Kush

    The protocol is core to every clinical research study; it is the plan. The protocol is used in designing the study, selecting investigative sites, developing the data collection tools, describing the study procedures and the analysis plan. Institutional Review Boards (IRBs) or Ethics Committees use the protocol as the basis for approving whether a study can be initiated. A well-constructed protocol can ensure common understanding of the study objectives and procedures to be implemented, there

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  • From Poison Squad to Industry Regulator: A Historical Perspective of the FDA

    18 April, 2017 Robyn Barnes

    It hasn't always been this way. If you take a historical perspective, the FDA has been in the game for nearly 200 years.

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  • CGMP Amendment for Finished Pharmaceuticals

    18 April, 2017 MasterControl

    In December 2007, The Food and Drug Administration (FDA) announced amendment to its current Good Manufacturing Practice regulations for finished pharmaceuticals.  They amended the regulations to modernize or toclarify some of the CGMP requirements, as well as harmonize some of theCGMP requirements with those of other foreign regulators and other FDAregulations. These amendments are also consistent with current industrypractice.

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  • An Analysis of Heparin, Accountability and Pre-emption Where Are We Now?

    18 April, 2017 Christine Humphrey, Esq., Fuerst Humphrey Ittleman

    First in a two-part series, (second part)

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  • Navigating the FDA's New Requirements for eCTD Submissions - Pharmaceutical Industry

    18 April, 2017 Antoinette Azevedo, Founder of e-SubmissionSolutions.com

    The United States Food and Drug Administration (FDA) is taking concrete steps to require the submission of all types of regulatory communication in electronic format. Globally, regulatory authorities are all moving to require electronic submission of regulatory communication. The reasons are many but one reason is clear: the public safety responsibilities of the regulators requires significantly faster access to content that can be supported by paper format.

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  • Why the 'Band-Aids' Keep Falling Off

    18 April, 2017 Vivian Bringslimark, President HPIS Consulting, Inc.

    When we cut ourselves, we automatically reach for a Band-Aid®. Why? It stops the bleeding and we can quickly return to whatever we were doing before the accident happened. Without a lot of fuss, we resolve a messy situation and expect the cut to heal in a few days. Having a box of these adhesive strips on hand allows us to reach for them again and again. The danger in applying a Band-Aid so automatically is that we fail to stop and inspect just how deep the wound really is. Maybe it wi

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  • Find Your Place on the Biotech Maturity Model and Make Better IT Decisions

    18 April, 2017 John Postle

    As information technology plays an ever-increasing role in drug discovery and development, emerging biotech firms can better manage their IT spending by using a three-stage maturity model to determine their needs now and in the future.

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  • America Leads the World in Cancer Research Investment

    18 April, 2017 Robyn Barnes

    The Pharmaceutical Research and Manufacturers of America (PhRMA) reports that America's pharmaceutical research and biotechnology companies are the primary source of R&D funding for new medicines, both for projects in their own laboratories and for research licensed from other sectors. Industry-wide spending on research reached a record $58.8 billion in 2007 - nearly double the National Institutes of Health's entire budget - and is a major reason why America leads the world in developing cures

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  • Five Essential Elements of Computerized Systems Used in Clinical Trials

    18 April, 2017 MasterControl

    In a recent statement announcing the FDA’s partnership with Duke University aimed at modernizing clinical trials, Janet Woodcock M.D.—the FDA’s deputy commissioner, chief medical officer, and leader of the Critical Path Initiative—stressed the importance of technological advances in clinical trial processes. “To ensure the safety of clinical trial participants and to improve the health of the public, the clinical research enterprise needs to evolve,” D

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  • FDA's Evolving Civil Money Penalty Authority:Simple Violations Can Lead to Major Costs

    18 April, 2017 Vernessa Pollard, Counsel in the FDA and Healthcare group at Arnold & Porter LLP, and Mahnu Davar, Associate in the FDA and Healthcare group at Arnold & Porter, LLP

    The U.S. Food and Drug Administration (FDA) has several enforcement tools at its disposal, including warning letters, injunctions, seizures and criminal prosecutions. While most industry professionals are familiar with these enforcement tools, FDA's civil money penalty (CMP) provisions may be less familiar to some. In the past five years, CMPs have emerged as an important enforcement tool as Congress has increasingly expanded FDA's authority to impose such penalties. With the expansion of FDA

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  • How Will the FDA's New Clinical Investigations Guidance Affect Pharmaceutical Companies?

    18 April, 2017 MasterControl

    Discusses how the FDA?s new clinical investigations guidance will positively affect pharmaceutical companies in light of recent news on the relationship between FDA and the industry

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  • Writing and Maintaining SOPs: Drudgery or Delight?

    18 April, 2017 Katy McMullin, Senior Professional Services Consultant at MasterControl

    "SOPs! We don't need no stinking SOPs!"

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  • Global Harmonization Task Force Final Document: Standards in the Assessment of Medical Devices

    18 April, 2017 Marci Crane

    The following article is a Q&A regarding the release of the Global Harmonization Task Force Final Document: Role of Standards in the Assessment of Medical Devices (acknowledged in this article as the RSAMD final document).1 Q: What is the Global Harmonization Task Force (GHTF)? A: The GHTF is a voluntary group that consists of trade association and medical device authorities from the USA, Canada, Europe, Japan and Australia. Q: Who is the authoring group for the RSAMD final document

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  • Overcoming the Top Three Project Management Challenges

    18 April, 2017 MasterControl

    During the course of the development of a new medical device, project managers inevitably come across three major obstacles to efficient project management: regulatory constraints, resource limitations, and on-time delivery. Prevailing over these challenges may have less to do with better planning and improved project execution and more to do with the management systems employed during the product development cycle.

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  • Can Medical Device Manufacturers Speed Innovation and Lower Costs while Increasing Quality?

    18 April, 2017 Daniel R. Matlis, Founder and President of Axendia

    Medical device manufacturers have consistently focused on bringing innovative products to market. To achieve this, most companies have implemented sequential design and manufacturing processes to ensure regulatory compliance and the highest possible quality.

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  • "Two Roads Diverged": Current Issues for the Medical Device Industry

    18 April, 2017 MasterControl

    Riegel vs. MedtronicDonna Riegel, a New York resident, has sued Medtronic, a Minneapolis based medical device maker, on the grounds that a Medtronic catheter device exploded during her husband’s angioplasty procedure and seriously damaged both his kidneys and mental capacity.  Though it was cancer that eventually claimed the life of Mr. Riegel, Donna Riegel’s attorney is suing for $5 million dollars on the grounds of inflicted injuries during the aforementioned procedure.

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  • Virtualization: Taking Advantage of Part 11 to Save Money

    18 April, 2017 John Avellanet, Managing Director, Cerulean Associates LLC

    MasterControl recently interviewed John Avellanet, the founder of the FDA regulatory intelligence and lean compliance program for executives and business owners, SmarterCompliance™, and the Managing Director of Cerulean Associates LLC. He is the author of more than 35 articles on lean compliance, Part 11, and quality systems, a contributing author to the book Best Practices in Biotechnology Business Development, and a frequent speaker with FDA officials.

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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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  • Writing and Maintaining SOPs - Sep 09 - B&B Article

    18 April, 2017 MasterControl

    "SOPs! We don't need no stinking SOPs!"

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