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  • Main Subject - Buyer Beware: Protect Yourself When Hiring Contractors or Consultants

    Did you know that when you hire someone to do work for you that you may
    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
    legally not own that work!?! Not unless you obtained an agreement tha
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    t states that ownership of the entire work is being transferred to you
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    upon final payment. Be it work with a graphic designer, copywriter, g
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ostwriter, photographer, web designer, software programmer, etc. etc.
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    Know the limits of your contracts.<

    EXAMPLE: Let's say you hire a phot
    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
    ographer to take your photo for your web site. You have an agreement, p
    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
    ay them upfront, and they agree to send you the photo in a CD. So, you
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    put the photo on your web site AND your letterhead AND your business ca
    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
    rd. The photographer sees your photo on these items and send you a bil
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    l. Or they send you a request to stop using that picture unless you pay
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    them for each other instance that you used that photo. Yes, both these
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    things are legal!

    PROTECT YOURSELF! I know the laws and yet I've been
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    burnt. I had an verbal agreement and when I went to "use" that agreem
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ent I got in some hot water. Get the agreement in writing or don't wo
    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
    rk with the person. While I hate saying this, not everyone's "word is
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    heir bond" and people forget months down the line what they had origina
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    lly agreed up. So, to repeat. Whenever you work with someone get an ag
    .

    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
    reement in writing. And if you already have an agreement, look at it t
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    o see who owns what and get it fixed so that you own the work -- pronto


    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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