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  • Social Articles - Katrina: The Lessons Unlearned

    For the past year, the administration has been playing catch-up for the fallout of th
    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
    eir infamously slow and undeniably inadequate response to the devastation and human s
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ffering caused by Hurricane Katrina. Staff resigned, were transferred or fired, and w
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    were assured that now all emergency services were coordinated and response time in t
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    e future would be immediate for any perceived threat to American citizens.

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

    Combination pro
    one year after the Gulf disaster, open warfare broke out in the Middle East. American
    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
    s in Lebanon, cowering under artillery shells, rocket attacks, and the loss of basic
    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
    menities including electricity, water, food, and medicine screamed for help to make t
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    eir escape.

    Again, the red tape, the lack of willingness to step forward, to take re
    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
    ponsibility, to make decisions or to issue orders, prevailed. As Italy, France, and o
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    her nations quickly moved to get their people out, the most powerful and rich nation
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    on earth dithered.

    Embassy staff had no answers for the frantic incoming calls. Tour
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    sts, students, and employees were told "We're working on it." Seven days after hostil
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ties began, a cruise ship started to evacuate, taking out 1400 of the more than 8000
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    eople begging for a route out. Embarking passengers were required to sign an affidavi
    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
    agreeing to reimburse the government for their travel - rescinded only after a publi
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    c outcry.

    The lessons of Katrina were clear and simple: any response must be expedit
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ous or it is worthless. Despite the hundred of stump speeches and the endless public
    .

    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
    osturing, the government has again proved to be disorganized and helpless in the face
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    of a humanitarian threat.

    The lessons have been ignored. We forget that at our peril


    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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