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    "I am more afraid of an army of 100 sheep led by a lion than an army of 100 lions led by a sheep." -Talleyrand

    As you rise in power and position you will attract enemies. An old ma
    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
    xim teaches us to judge men by their enemies not by their friends. There will always be those who plot against you. Accept that now before you go any further and your life will be e
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    sier. Cloud yourself with delusions that you are universally loved and you will learn the harshest lessons of defeat.

    Know your enemies! They are active and plotting against you. H
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    nry Kissinger correctly stated that even paranoids have enemies. A little paranoia in a leader is a healthy thing but make sure to keep it in check. Nothing will destroy you faster
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    han complete paranoia. Locate your enemies thru your spies and informants. Beware of double agents. Every spy has the potential to spy against you too. Never reveal too much to your
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    spies, only enough to keep them close to you and dependant upon you. The best spies are those who stand gain from your victories.

    The hardest enemy to spot is the one that plays to
    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
    your vanity. A smart enemy will pose as a friend to get close to you. He will flatter and cajole you into a false sense of security, and when you are your most vulnerable, he will
    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
    trike without mercy. Beware of flatterers and sycophants. They will be the most likely to turn against you at the first perceived slight. Those who speak loudest of their love for y
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    u are working the hardest to convince others of their sincerity. A truly loyal follower will always work in silence for your cause, since both his cause and yours are the same.

    Now
    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
    that you have spotted and identified your enemies, keep them close to you. This old mafia adage has great truth. Give your enemy a position within your immediate power structure. Th
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    s will provide for two possible outcomes. By working closely with you, your enemy can be turned into an ally by identifying commonality of purpose. Remember, your enemy is never the
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    villian in his personal version of the story. Never ascribe base motives or evil intent to your foes. Find their true point of contention. Why do they disagree with your leadership
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    If you can identify this and then work to build bridges of commonality, you will create your strongest ally and supporter. His power is based on yours and, since you are united in
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    urpose, he will work for you.

    However, if there can be no compromise or commonality, give them enough rope to hang themselves. Give them the power and authority they crave. Stand b
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ck and watch. Never lose your grip on ultimate authority. Publicly praise your foe for every achievement. Point out your enemy's achievements and laud their contribution to the depa
    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
    tment. If your enemy speaks against you quietly, your praises will cause the staff to begin to distrust your enemy for speaking against you. He will be labeled an ingrate; didn't yo
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    u show your trust and faith in the person by elevating him? How can he talk bad about you when all you do is praise him? It does not hurt to have your supporters spread these seeds.
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    Gratitude is a dangerous emotion to expect from anyone but people place great stock in it. Use this to your advantage but never rely on gratitude alone as the basis for loyalty.

    As
    .

    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
    they think to further their cause by speaking out against you, they will only serve to destroy themselves. With time the outcry will grow against your enemies (fed and managed by yo
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    r supporters) until such time as you must acceed to the will of department and remove him from power. You will succeed in removing their fangs by feeding public opinion against them


    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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