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  • Cases - Should StopBadWare have Unilateral Control ?Over the Internet?

    Recently StopBadWare.org has been taking complaints about websites on the Internet where a certain webs
    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
    ite might have illegal pop-ups, spyware, badware, etc and then they lock them out of the Search Engines
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    , but putting a page between the site and the Search Engine. Unfortunately, this is an issue in its sel
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    f because it is run by some folks from Harvard Law, which are hardly politically neutral and graduates
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    have been known to abuse power in the public sector.

    One has to wonder if those who started this group
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    and have some credible names behind them as Board of Directors, which are deeply involved in the proje
    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
    ct; thought all this thru carefully, because being in a very competitive service industry in our sub-se
    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
    ctor it is known fact that many complaints come from competitors. A recent SEC survey showed over 85% o
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    f the complaints coming into the SEC about broker dealers were invalid? How many coming into StopBadwar
    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.org are?

    And if this group does not go after false complaints, then is this a new strategy for those
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    who wish to reciprocate against their competitors to re-level the unleveled playing field created by S
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    topBadWare.org? The fact is that we cannot allow regulators, lawyers or bureaucrats to control the Inte
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    rnet. The FTC has been impotent in stopping SPAM, Sploggers, hackers and identity thieves in the past.
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin

    Instead of fixing the problem they PR their regulatory prowess and then give authority to a group of l
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    awyers from Harvard Law to control the Internet? No wonder Europe wishes to bow out of the US control o
    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
    ver the Internet. Having been personally involved in watching how this group works I see nothing but Ab
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    use of Power from my perspective.

    This whole thing seems like a great idea in theory, but in practice
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    one cannot get a hold of anyone sometimes for 24 to 48 hours and if you are in a small business, you kn
    .

    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
    ow how serious that might be to cash flow. This is not fair to the online businesses, which work hard e
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    very day to service the very consumers you are claiming to protect. I hope this propels thought in 2007


    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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