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  • Top Reference - Christian Forums: The Heroic Battle Between the Forces of Good and the Demon of Anti-Access

    Saturday I was hangin’ ten on my Dell when I ran across a Christian Forum. Not just any Christian forum, THE Christian Forum. How did I know? It said so: ChristianFor
    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
    um.com.

    I looked at a couple of the posts and thought it might be cool to sing a few lines of “Pass It On” while holding cyber-hands with my bros around the warm glow of
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    a CRT. Just like camp.

    Kinda made me misty…

    So I checked out the registration and applied. Being the self-promoter I am, I chose “WhoreChurchcom” as my user name. Co
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ple of extra visitors can’t hurt, huh?

    So I hit submit expecting to be ushered into the stained glass chat rooms of cyberdom.

    Drats! they have to approve me first. Jus
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    when I was ready to test my speedy typing skills.

    My hunger for fellowship still burning in my gut, I fire up Google and search for “Christian Forums”. Sure ‘nuff, the
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    e’s quite a few out there. I settled on one and clicked.

    With blazing T1 speed, I was propelled to the hallowed halls of CrossWalk.com.

    I quickly located the registra
    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
    ion form and entered my information. With no little amount of anxiety I hit “submit”, hoping against all hope that no moderator had to approve my admission, denying me 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
    ecious moments of blessed fellowship.

    Hallelujah! All I had to do was confirm my email address and I was in! A few moments and I was there: In The Cyber Cathedral wit
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    Hundreds, nay Millions of my Fellows.

    A topic caught my eye: “Walking in Truth.” I read with great anticipation my Brother’s thoughtful post. Did I have a word of en
    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
    ouragement? Correction? Addition? My fingers, Matrix-like, became a blur over the keyboard. First one post, then two.

    I was in the Holy-Spirit-Helpin’-Zone.

    Within
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    few moments I had helped five of my fellow pilgrims. Spent, I collapsed in my chair. Emotionally drained yet strangely fulfilled. I was a part of The Body.

    Needing su
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    tenance, I used the last of my strength to stumble to the refrigerator where I passed out. I heard an angel saying, “Get up, the journey is too much for you,” placing a
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    iet Coke in my weakened hand and one of my wife’s oatmeal cookies in my mouth.

    Strengthened by the Angel Food, I returned to my chair. Had another caring soul responded
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    to my posts? Is there a word of encouragement for me? A “Thank You” from someone whom I just saved from a life of error?

    Access Denied.

    What? Certainly this is a gli
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ch. I tried logging in again…Access Denied. Possibly this must be a Demonic Attack spawned of the Evil One. Access Denied. Fowl Spawn from Earth’s Bowels, I will not
    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
    e defeated! You will not deny me access!

    I logged in again. Again the screen taunted me: Access Denied. Demon of Anti-Access I rebuke you in the Name of Jesus!

    Stil
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    the 17” Diagonal Imp taunted me: Access Denied!

    Wait! How silly of me. Certainly in my euphoric fatigue I had forgotten the password. This was no demon, it was simp
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    y my humanity.

    I clicked over to email—and that’s when it happened. No, it cannot be. But yes, it had.

    Ben, Moderator of the Cross-Walk, notified me. I had violated
    .

    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
    ule 20 and been banned from the forum.

    Rule 20? Had I in my human weakness progressed far beyond the 10 Commandments and transgressed not rule 11 or even rule 18, but t
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    at hallowed “Rule 20”.

    Crushed I wandered into bed. “Been having fun on the computer, honey?” my wife inquired. Without reply I rolled over and sobbed myself to sleep


    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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