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    There can hardly be a driver in America who hasn't been cruising down the highway when the regular programming on the radio is interrupted for a test of the Emergency Broadcast System. A brief wa
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    rning that a test is about to occur is followed by a burst of tones that sounds like it's coming from a dial-up computer modem followed by a reminder that what was just aired was a test.

    Or, per
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    aps you live a tornado-prone section of the country like I do. If so, we probably share this similar experience. Absorbed in the work at hand, you hear a whine in the distance that at first start
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    es you and then makes you look at a clock and a calendar to confirm it's 11 a.m. on the first Tuesday of the month --the time local government authorities test the city's emergency warning sirens
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    If it isn't, you know your next step is to grab a portable radio and flashlight and head for the basement.

    I'm not sure exactly when this loose network of government officials, broadcasters and
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    local sirens coalesced into an organized system for alerting the public of an impending emergency - although it probably was the same time the USA entered into a protracted Cold War with the Sovi
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    et Union. However, I am certain the original planners of the system did not envision the existence of thousands of private TV channels and digital signage networks.

    Yet, that's exactly where tec
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    nology has taken us today. The existence of these networks gives corporations, universities, colleges, secondary and even primary educators, government agencies, the military and other institutio
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    s the opportunity to inform people within the reach of their private TV and digital signage networks of an unfolding emergency situation.

    I would argue that in some situations the ability of the
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    e networks to deliver highly targeted messaging to a select audience makes them even more valuable than a blaring siren or even a broadcaster. It's a sad fact of life that we live in a time when
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    lone person or a small group can perpetrate an act of evil so deplorable that tens, hundreds or even thousands of innocent people can come face to face with peril and possibly death. In those si
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    tuations, knowing where to go and what to do can mean the difference between life and death.

    In a school, at an airport, in a post office, at a shopping mall, around the campus of a large corpor
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    tion or even the confines of a small business, a digital signage network or private TV network can be used as a closed-circuit Emergency Alert System. "Terror Alert: Evacuate Terminal A," "Emerge
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    cy: Gunman in North Wing of Building," or "Warning: Fire On Third Floor -Use West Stairway to Evacuate." These are all vital, yet simple messages that these networks of flat panels and TVs can di
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    play to stack the odds in favor of saving lives.

    Additionally, with the right software, hardware and interface, the media servers used to schedule and playback digital signage networks and priva
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    e TV channels can be tied directly into the Emergency Alert System (EAS) to playback warnings of larger dangers, like tornados, flash floods and civil emergencies.

    In the next couple of columns,
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    I will lay out some of the technical details of setting up a digital signage network or private TV channel to support the EAS system. (Don't worry. You won't need to be an engineer or computer p
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ogrammer to understand what's required and how to employ it.) I'll also offer a few tips you might find valuable in preparing for emergencies.

    Often in our professional lives we get so focused o
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    our core task -be it selling more widgets, posting our school's social activities, class schedules and menus or welcoming visitors to our companies- that it is easy to lose sight of the bigger p
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    cture. We are professional communicators first. We have a powerful medium at our disposal, and we can help to make a difference and possibly save lives when an emergency situation presents itself


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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