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    Alligators and Crocodiles: New Indications for Use?

    This article provides current research in drug development and describes crocodilians, their immune function, the search for new antibiotics, antimicrobial peptides (also known as host defense peptides) and future research for anti-cancer agents. Introduction Many years ago, John R. Brinkley, who had been called America's most dangerous huckster, recommended a number of concoctions to treat erectile dysfunction. Included among them were rhinoceros horn and boiled alli...
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    Aging Revisited: an Amazing Continuous Process

    This article will briefly discuss the definition of aging, what it means to age, the process itself, why we age and anti-aging methods designed to increase longevity. Active research has indicated a number of medications have increased the life span in mice and other laboratory animals. Duplicating the results in human patients could make anti-aging medications the next category of truly miracle drugs. "All the world's a stage, And all the men and women merely play...
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    Insulin: The First Truly Miracle Drug

    This article will discuss diabetes, the process of the discovery of insulin and provide brief biographies of two intrepid people involved. Introduction Although a number of so called blockbuster drugs claim to be miracles, none has yet reached the status of injectable insulin. It was the first drug to treat diabetes mellitus that could virtually raise the dead, enabling dying children to laugh and play again and to lead a somewhat normal life. 1 Insulin transforms a ...
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    David Nachmansohn, Nerve Gases and Electric Eels

    Regulatory professionals in the pharmaceutical industry should know the historical background about David Nachmansohn and his war time effort to discover the antidote for nerve gases and other organophosphates. They may wish to learn how electric eels were used in his research. For those who work for medical device companies, electric eel cells are being studied to develop artificial cells that may be used to power future implantable devices. The article also contains ge...
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    Book Excerpt: The Medical Device Validation Handbook, Chapter 1: Introduction and History

    The following chapter is an excerpt taken from The Medical Device Validation Handbook . Process and Design Validation—Regulatory Concerns Countless Warning Letters or FDA 483s include the following violations: “Failure to ensure, where the results of a process cannot be fully verified by subsequent inspection and test, that the process can be validated with a high degree of assurance and approved according to established procedures, as required by 2...
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    Teaching: An Integral Responsibility for Regulatory Professionals

    Quality management standards are replete with training requirements. Just look at the quality system regulations (current Good Manufacturing Practices (CGMPs)) for pharmaceuticals, biologicals and medical devices in the US and the International Organization for Standardization (ISO) 13485, the EU quality management standard for medical devices. According to both, training needs must be identified and training must be conducted by qualified personnel. ISO 13485 ad...
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    Fruit Flies––Powerful Foot Soldiers in Genetic Research

    “ Time flies like an arrow; fruit flies like a banana.”––Comedian Groucho Marx Most everyone knows fruit flies gravitate toward bananas and other overripe fruit, and almost magically appear in kitchens around the world. Less well known is the fact this insect species has been used for more than 100 years to study genetics and developmental biology. Perhaps the most remarkable discoveries in these fields have come from research with this persistent pest. Fruit flie...
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    Tumor Paint—A Novel Approach to Enhance Surgical Resection

    Imagine an imaging agent that “lights up,” or stains (paints), malignant tumors and other cancers. This tumor paint, derived from scorpion venom, potentially could help surgeons resect tumors with the least amount of extraneous damage to surrounding non-cancerous tissues. 1 Tumor paint thus could provide a new pathway for both the diagnosis and treatment of tumors. Regulatory professionals should be aware of this exciting discovery as it could affect their compani...
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    Two Extraordinary Medical Writers: Lewis Thomas and Sherwin Nuland

    I taught a scientific writing course this summer at a local college. One of my goals was to introduce the students to exemplary writers and to suggest each student attempt to emulate their styles in composition. While there are a number of outstanding medical writers from which to choose, two are truly exceptional and in a class by themselves. Both write the kinds of sentences you like to read over and over again. I have written about them before, but their contributions ...
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    Leprosy––Not Yet Consigned to History

    The word leprosy brings to mind a gruesome disease that separates its sufferers from society and continues to strike fear into communities, much like Ebola. While the genome for leprosy has been sequenced and there is a drug cocktail that effectively cures the disease, its mode of transmission still is unknown. A disease that dates back through millennia, leprosy so far has eluded efforts to find the final piece of information that might eradicate it from the world per...
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    John Snow—The First Epidemiologist?

    Epidemiology studies often play an important role in the approval or postmarketing surveillance of healthcare products. In this article, the author discusses what likely was the first epidemiology study––renowned English physician John Snow’s research into a cholera outbreak in London in 1854. In addition to his studies on cholera, Snow was a pioneer in anesthesiology whose work contributed to the development of modern surgery. This brief look into the life and work of S...
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    The Science Behind What You See

    No other sense organ is as critically important to the activities of daily living as our eyes. This article, which describes sight and the vision process, is the third in a series the author is writing about the five senses. Articles on hearing and smell were published in Regulatory Focus in 2013. 1,2 This article briefly discusses eye anatomy, the miracle of vision, the evolution of sight and ocular diseases (cataracts in particular), and provides references for furth...