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    I’ve been active in consulting, offering seminars and speeches, and customized training programs for more than 20 years.

    During that time,
    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
    I’ve done hundreds of seminars and speeches, public and onsite, and I’ve trained thousands of people, many of whom have given me written eva
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    luations and letters praising their experiences.

    Tonight, in gathering some quotes to use in a seminar brochure, I had to wrestle with a fe
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    w important questions:

    (1) How old is too-old, if you have a reference or testimonial?

    (2) If the reference’s company has been purchased b
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    y another entity, do you use the original company name, the updated one, or both?

    (3) Can you count on someone to be willing to back-up a r
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    eference he wrote, say more than five years ago?

    Maybe, I’m a rare breed to be concerned about such things, but I think there are some pote
    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
    ntial ethical as well as practical issues at stake, especially if you have been consulting, coaching, or simply running a business for many
    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
    years.

    Let’s say someone gave you a glowing testimonial about a program you did ten years ago, saying you were dynamic, interesting, releva
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    nt, and your seminar was “The best I’ve ever attended!”

    (I have some of those; really, I do!)

    Can you use it, today? Still, I believe I am
    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
    all of those things and my programs are great.

    But is it fair to attribute these qualities to myself, now?

    I say, why not? I earned the a
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ccolades and they never bore a “use-by” date, like ground beef or milk at the supermarket.

    The next issue is a little trickier. Some compan
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ies change names without changing their basic composition or products. Sperry became Unisys, so there’s no biggie in listing it, I suppose.
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod

    Two of my references are from Baby Bells that we’re later merged into AT & T and Verizon. If I didn’t use these modern names, who would rem
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ember, or not be confused, if I said Pacific Bell and Nynex, which is where my references hailed from.

    I have some “pure” AT & T references
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    , too, so that’s not too much of a problem, I suppose.

    But what about General Foods, which became Kraft or Flying Tigers, which was bought
    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
    by and merged into Federal Express? Perhaps it’s the same thing, but I’m not so sure.

    Finally, and maybe this is the most serious challenge
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    , can we expect people to stand behind testimonials they gave years ago?

    I believe they should! You may have trouble finding these folks af
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ter companies have come and gone and have downsized, but your contacts should prop you up as they said, or certainly implied they would do.
    .

    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

    If you’ve been great at what you do for years, then why not tap that wealth of good will that you have stored in those references?

    Certain
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ly, you can use more current testimonials, and you should insert a few, but older references should age well, like fine wine, and like, you!


    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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