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    Hello to all,

    I was asked this general question last week by a loyal reader. It was so general that at the time I decided not to answer until I had answered more important questions. But after some tho
    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
    ught. I believe the question to be important to the reader, as well as to others readers.

    There are so many situations one could find themself in regarding the police that I could'nt possibly address
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    hem all. But I will attempt to answer this question in a general, generic and abstract way.

    Most encounters with a law enforcement officer are concerning some non-serious manner. Occasionally, it may
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    be serious. But also keep this in mind: a small and seemingly simple situation can escalate to something serious. This is why I advise anyone who is stopped or questioned by the police to take it seriou
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ly. This authority can wreck havoc with your life.

    My first advice that many of my readers are familiar with is to NOT answer any questions or say anything when it's obviously a serious crime. Just sh
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    t up. The officer will surely attempt to play a mind game with you by stating, " If you have nothing to hide or if you're not guilty, why not talk to us"? Don't fall for this tactic! Many times while
    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
    looking at police stories or crime dramas, I become so upset that I can't see straight. A many people have been placed in jail for life for voluntarily talking.

    It is not your job to help him convict
    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
    you. It not your job to PROVE your innocence. He must prove it. That's a constitutional requirememt. Even if you're guilty, he or rather the district attorneys' office must prove it. I'm not trying
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    to help a guilty person get away with anything, but the law is clear: better to let one guilty person go than convict one innocent person unfaily.

    Now, when you're questioned by the police or have to e
    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
    gage him in any matter, always remember to speak softly and be courteous. Be firm, but remember, every comment you make will be used against you. I never understood why they always said, 'your commen
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    s CAN be used against you". Trust me, they WILL be used against you.

    Try not to give him anything voluntarily. If you decide to answer, only answer what you were asked. The only exception that I can
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    think of off the top of my head is if your voluntary statement is that of a witness to a crime. Then my all means assist the police. it's your civic duty. Just don't get caught up and get yourself in a
    dd to the challenges in developing combination products:

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

    Here's the major rule and thought that should quickly enter your mind: Am I being questioned as a witness or as a potential suspect? The answer to this question should regulate how much yo
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    u say or don't say. Always remember to protect youself FIRST!

    Lastly, when in doubt, SHUT UP. If he has anything against you, he's going to arrest you anyway. Invoke your right to seek an attorney. H
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    is your only true friend. The police is only your friend when you're in trouble, or have call or seek his assistance or any neutral situation he happens upon. If you're brought up on charges, and the 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
    strict attorney decides to prosecute you, you'll see. He will come at you with the full power and authority of the state. That's his true boss. Theoretically, the district attorney is supposed to be a
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    n advocate for you also if he believe's you're innocent, but believe me, more times than not, if charges are dropped against you, it was'nt because they found you're innocent, it was becauce they could
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    nt PROVE your guilt!

    As many of you know, my mission in life is to expose all unfair law enforcement officers and their unfair tactics. Why? I was once a rogue officer myself. I, through the years h
    .

    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
    ated myself so much that it literally made me sick. I also feel my eventual death may come from the hands of a rogue cop. He does'nt want me to reveal all of his unfair tactics and procedures. But as
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    've already stated on many television shows, I DON'T CARE! I would rather die for something good then something bad.

    Read my controversial book called COP OUT. You may learn a lot more. Take care all


    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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