• 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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  • New FDA Guidance to Balance Risks and Benefits of Drugs

    18 April, 2017 MasterControl

    FDA to Provide Emerging Drug Safety Information

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  • All New Electronic Submissions Must Conform to eCDT format - For Pharmaceutical Industry

    18 April, 2017 Lane Hirning

    For well over a decade, there has been an initiative by the International Conference on Harmonization (ICH) to standardize formats for new drug applications in the U.S., Europe, and Japan (where the majority of new medicines are developed).  In the past, the format and organization of submissions varied by country, which made it difficult and time-consuming for a U.S. drug company, e.g., to submit an application for drug approval in Japan or the United Kingdom, and vice versa. A com

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  • Three Steps to Improved Compliance Management - Pharmaceutical Industry

    Dave Richardson, Senior Analyst, Cutting Edge Information

    It's no secret that pharmaceutical companies have great concerns about their overall compliance efforts. In fact, in several conversations that I've had with executives from marketing, sales, clinical, medical and other functions, it's rare to hear that compliance isn't a hot-button issue.

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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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  • CHANGING TRENDS: Clinical Research Personnel Qualifications!

    Liz Wool, CCRA, CMT, President and CEO, QD-Quality and Training Solutions, Inc.™

    In the last decade, clinical researchers have conducted clinical trials where their lack of knowledge of human subject protections embodied in Good Clinical Practices and ethical conduct for research (Belmont Report, Declaration of Helsinki) has resulted in clinical trial misconduct and subject deaths. Notably, these cases were reported in both our news media and professional publications.

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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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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  • How to Avoid Common IND Submission Pitfalls

    12 April, 2010 Meredith Brown-Tuttle, RAC, Chairperson of the RAPS Publication Board

    An Investigational New Drug Application (IND) is like an orchestra - it brings together many players with different specialties that need to work together in harmony to create a synchronous melody (in the case of the orchestra) or message about the compound (in the case of an IND). With one instrument out of tune or with one musician who does not play his or her part there will most certainly be a displeasing sound to the ear and a composition that is thrown off. The same can be said for a secti

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  • Analytical Method Validation: What is Expected?

    17 April, 2017 Michele Piepoli

    The Food and Drug Administration (FDA), International Organization for Standardization (ISO), European and other regulatory authorities have requirements and expectations regarding the performance and documentation of an analytical method validation.

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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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  • 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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  • Adverse Event Reports Hit Record High

    Sharon Phillips

    According to FiercePharma, the number of deaths (4,825) and serious injuries (21,000) associated with prescription drugs during the first quarter of this year was higher than it's ever been.1 These numbers represent nearly a threefold increase over the previous quarter, and a 38-percent increase over last year's quarterly average.

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  • Current Political Climate Favors Passage of Drug and Device Accountability Act of 2009

    Sharon Phillips, Marketing Communication Specialist, MasterControl, Inc.

    Although essentially the same as its 2008 predecessor, the recently announced Drug and Device Accountability Act of 2009 is much more likely to become law in today's more favorable, "accountability-conscious" political climate.

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  • Medical Device Lifeline - Why Do We Have Repeat Investigations?

    Nathan Conover, Sr. Partner, Pathwise

    Repeat CAPA investigations are arguably one of the largest areas of concern for quality managers today. Despite many firms taking the recommended corrective action, repeat investigations throughout the industry have accounted for as many as 30% of all open investigations- or 1 in every 3. What's going wrong? Why is this happening to so many of us?

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