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    Beware of these myths about copyrighted materials:

    If it doesn't have a copyright notice, it's not copyrighted.
    That use to be co
    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
    rrect. However, almost everything created privately and originally after April 1, 1989 is copyrighted and protected whether it has a no
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    tice or not.

    If I don't charge for it, it's not a violation.
    Wrong again. It is a violation if you copy and give copyrighted work
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    away. There are serious penalties and damages awarded if you hurt the commercial value of the property when giving it away.

    If it's p
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    osted to Usenet it's in the public domain.
    Nothing is in the public domain unless the owner has donated it into the public domain
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    r the works copyright has expired.

    My posting was just fair use!
    Fair use is usually a short excerpt. It was created to allow thi
    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
    ngs such as commentary, parody, news reporting, research and education about copyrighted works without the permission of the author. It
    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
    should not harm the commercial value of the work. That is result in interference with the works creator economic livelihood.

    If you
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    on't defend your copyright you lose it.
    As it was stated before, unless the owner has donated it into the public domain or the wor
    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
    ks copyright has expired all created works remain copyrighted.

    If I make up my own stories, but base them on another work, my new work
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    belongs to me. This is what is called of what are called a "derivative works" -- works based or derived from another copyrighted work.
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    If your work include proprietary information from another's work, you must obtain permission. There is an exception -- criticism and p
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    arody. The fair use provision says that if you want to make fun of or criticize another's work you can do so without permission. They
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    can't win, defendants in court have powerful rights.

    Copyright infringement is a civil law. You can be sued for damages. In some cases
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    you can be charged with criminal felony.

    Who does it hurt -- in fact it's free advertising.
    That is not your choice if you are n
    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
    t the owner of the work. You must get permission to use copyrighted work. Miss use can negatively affect the creators economic liveliho
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    od.

    I received it as an email, can't I post it?
    Email is copyrighted. Unless reprint rights have been extended to you by the owne
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    r you can not post it. It can be discussed in your writings to others. But never transmitted verbatim without the owner's permission.

    .

    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
    o what is allowable?
    The owner of the work owns all rights to their works. If you have even the slightest doubt whether a piece of
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    work is copyrighted or in the public domain, seek out the owner and get permission.

    Beware of these myths about copyrighted materials


    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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