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    I found it important to clarify for employees what “deal-breaker” behavior was at my company. These are the things I insisted would not be tolerated and w
    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
    ould lead to immediate or ultimate termination, depending on the nature of the infraction of these hard and fast rules. Here are the behaviors I would not
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    tolerate:

    1. Gossip. Rumors can be incredibly disruptive to a company. A lack of information can get rumors started, and frank explanations can usually s
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    op them. However, some employees thrive on the admiration of others when they seem to be “in the know.” Define gossip as clearly as you can and tell emplo
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    yees what you expect them to do when they hear it. First and foremost, that you don’t repeat it. Along the same lines of gossip, remind employees that all
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    e-mail sent or received on company computers is considered company business and not private correspondence.

    2. Violence or threatening or abusive behavio
    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
    . Termination should be immediate for any employee who engages in any form of violent or abusive behavior. Workplace violence includes threatened or actua
    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
    l abuse and can be verbal or physical. These behaviors only escalate with time and are never excusable. Any employees involved in workplace violence shoul
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    leave the workplace immediately and be placed on a paid leave of absence for a few days while you investigate the situation and consult with your attorne
    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
    . Don’t assume this couldn’t happen in your company—it’s estimated by the Occupational Safety and Health Administration (OSHA) that two million Americans
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    re victims of workplace violence annually.

    3. Dishonesty and theft. The term theft can include the theft of time, office supplies, and the use of office
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    equipment for personal projects. Set standards for what is acceptable use of company assets. Security experts say as many as 30 percent of workers steal,
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    esulting in an estimated loss of $50 billion a year from U.S. companies and contributing to as many as one-third of business bankruptcies.

    As for dishone
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ty, I have a zero-tolerance approach. I dismissed members of my accounting staff for what may seem to be petty reasons: one for using $5 of petty cash as
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    personal lunch money, another for telling me he was home sick when he was out of state on a long weekend vacation. If key staff members are not honest wit
    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
    you about small things, how can you be sure they will tell the truth “when it counts?”

    4. Substance abuse. Substance abuse is more rampant than most emp
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    oyers know. The U.S. Department of Health and Human Services estimates that from 6% to 11% of adults are substance abusers. Substance abuse costs U.S. emp
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    loyers an estimated $100 billion a year. Call your attorney to make certain you follow the Americans with Disabilities Act (ADA) requirements. Illegal dru
    .

    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
    s are expensive and have led financially desperate employees to commit fraud. They have also been implicated in violent behavior in the workplace.

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

    Companies that provide selfless information through particip
    to setting standards in your workplace and you will find a calmer atmosphere, less turnover, and more attention to productivity, growth, and profitability


    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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