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  • Main Subject - The Night Before Christmas

    'Twas the night before Christmas,
    And around the base of the tree.
    Prada, Gucci, with Dolce and Gabbana,
    Gorgeously wrapped
    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
    from the shopping spree.

    I waltz through the dizzy mall,
    And can't believe what I see.
    A hundred people in line,
    They wer
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    buying See's Candies.

    I enter the charming boutique,
    And met a scent heavenly.
    I say to the proprietor,
    "Two dozen Godiva
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    s, please."

    Then it's back to the house,
    I get a call from a friend.
    "What time's the party?"
    Well it all depends.

    Ferrar
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    s. Vipers. A Shelby or two.
    They surrounded the house, even a Cobra in blue.

    "How are you doing?"
    They all wanted to know.
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    They came for a party,
    Minus the white snow.

    I spoke to a sad colleague,
    He said he'd soon be departing.
    His company is sh
    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
    utting down,
    Due to stale and sterile marketing.

    They did everything as planned.
    They played by all the rules.
    They hired
    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
    Big Gun consultant,
    And bought all his training tools.

    Thumpity-thump, we heard a pounding noise.
    It came from outside, a slei
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    h full of toys.
    The driver came in, flushed from the high ride.
    He thanked his eight reindeer, for keeping in stride.

    He confes
    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
    sed that once, he worked for a big corporation.
    But they wanted nothing more, of his idea presentations.
    They respond, "We've be
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    n there, and done that.
    But all that ever got us, were plenty sales flat."

    They never tried again, to be on the safe side.
    They
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    started playing defense, and cast offense aside.
    Their sales began sagging, year in and year out.
    With no one to blame, for the
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    fiscal year drought.

    The stockholders were mad, and sold off their last shares.
    They took a huge loss, and couldn't see where they'd
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    erred.
    A business degree, can impress your tight boss.
    But profits are made, from sales and not loss.

    My friend chimed in, with
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    his dire situation.
    His voice seemed choked, with a dash of desperation.
    "My hands were tied, in saving the company.
    They d
    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
    idn't want change, they all seemed to agree."

    Nervous and anxious, of losing their own jobs.
    They made for the want ads, like a fren
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ied lynch mob.
    It became real quiet, while the staff made their last pleas.
    They glanced over their shoulder, like rats nibbling
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    on cheese.

    Santa agreed, as he was readying his flight.
    He said, "Ho, ho, ho, I understand you alright.
    You can't do much, with
    .

    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
    people nowadays.
    They're out of touch, their mind in a haze."

    There's a lesson to learn, for all my business friends.
    Look up.
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    Watch out. And cover your rear end.

    He leapt to his sleigh. He shot up out of sight.
    Happy Christmas to all, and to all a good night


    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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