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  • Answers - Regulatory Agencies In Washington DC Need On-Going Education

    Well it is time that we demand some on-going education for all bureaucra
    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
    ts and Washington DC based regulatory agencies, because it is rather obv
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ous they just do not understand or give a crap about free markets or fre
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    enterprise. These micro-managing morons do not get it because they have
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    never had to make a payroll or get a job done right and on-time.

    Instea
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    they waste all of our time making us learn their irrelevant rules and r
    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
    egulations. We must give these regulatory folks a taste of their own med
    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
    cine. We need to start by having them read Ayn Rand; Fountain Head and W
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    en Atlas Shrugged chapter by chapter and tack a test on each page.

    If t
    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
    ey fail to pass they lose their jobs and must be kicked out of their off
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ces and forego any pension paid for thru taxpayers monies. I believe tha
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    t; Regulatory Agencies and all employees, staff and bureaucrats in Washi
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    gton DC need and must be required to do On-Going Education. They need 10
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    credits per year and those two books are first and worth 3 credits each
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    with workbook assignment.

    We must teach these bureaucrats and Mongoloid
    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
    a lesson once and for all. Any person caught cheating or failing to comp
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    lete these tests must be fired and the taxpayer must be alleviated this
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    urden. If they are not smart enough to pass the tests they are fired. Ea
    .

    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
    h test must be faxed in and documented in the main government employee I
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    Database; Fair is fair even in Fairfax, Virginia. Consider this in 2006


    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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