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  • E-Folder - The Bloggers Handbook: What You Need To Know About Defamation

    Currently there are over 30 million blogs on the internet and thousands more being created each week. Assuming ownership of one blog per person, that's a minimum of 30 million people slinging around their personal opinions on all that exists under the sun. This is a good thing. The free exchange of thoughts and ideas is what prevents the world from becoming a stagnant pool of
    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
    dictatorship with the appropriate green scum floating on top.

    However, to steal a line from the movie Spiderman, 'With great power comes great responsibility'. Blogging has become a way for the voice of the people to be heard. We must be careful, though, not to abuse our power through thoughtless acts that hurt the credibility of bloggers and blogging. One place tha
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    t continues to be our Achilles heel is when good posts go bad.

    In the United States, libel and slander are the two categories of defamation. In many states, courts have begun treating them the same as the only difference between the two is that libel is a false written statement about a person, place or thing that harms his/her/its reputation while slander is the verbal act o
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    f the same offense. Whether blogged on the internet or whispered offline to your mother, the common denominator is that what is said is false.

    Since I'm psychic, I already know what you are thinking. 'The First Amendment of the US Constitution protects me. As long as it is the truth, I can say whatever I want.' Well, sort of. As crazy as it sounds, truth is not the s
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ilver bullet defense for every case of libel or slander. A judge may require that besides being true the information relayed is in the public interest to know.

    So reporting that the CEO of a major corporation had been caught pilfering money from the employees' retirement fund would probably get dismissed from civil court whereas telling the world that your neighbor has smelly
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    feet could get you into more trouble than you want. Even if it were true, why would it be in the public interest to know that your neighbor's feet could clear out Yankee Stadium?

    Now, the First Amendment does protect your right to an opinion. If you think that the Mr. Squiggly Toddler Toy is a piece of crap, you are certainly free to tell anyone within earshot as long as you
    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
    make it clear that it is your opinion on the subject. Likewise, if a person puts forth a negative sentiment with regards to their experience with you and it is clear to any reasonable person that it is their opinion, your legal recourse against them is severely limited.

    Parody and satire are also protected. If they weren't, Saturday Night Live and South Park would have never
    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
    made it past the first episode. And criticism of a public performance such as a symphony, a play and even a book is protected under the Fair Criticism and Comment clause.

    Now the internet contributes some interesting layers of complication to the whole blogging shebang. Instead of being contained in a localized area, libel has the potential to cross international borders and
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    not every country handles these cases the same. One of the major problems courts around the world are having to deal with is the one of jurisdiction. If I live in the US and I libel someone who lives in the UK where exactly does the case take place and who's laws do we go by? Several cases have set a scary prec
    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
    edent that leans towards being able to sue anywhere around the world for libel published on the internet.

    Then there is the issue of third party liability. Say you are a responsible blogger who is careful about her posts to avoid a troublesome libel accusation. One of your readers posts a libelous statement on your blog. Can you be held responsible for that person's actions?
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    Well, so far the law has only made provisions for internet service providers stating that they cannot be held responsible for how their customers use their services (as it pertains to defamation). Likewise, blog service providers such as Google and Six Apart would likely be immune to any lawsuits arising out of a person's use of the service.

    Whether or not you would be held r
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    esponsible may come down to if you moderate your comments. If you allow comments to be posted automatically, you might be protected under Section 230 of the US Code (for US Citizens). It may be a different story, however, if you approve comments before posting them. It
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    could be argued that your posting of the comments equates your agreement to them. To date, no one has shown up in court to argue this, hence the fact that we are kind of forced to make it up as we go along.

    Defamation is a tricky issue and one that needs to be tread carefully if one is to avoid landing in court. Here are a few tips to help keep you out of trouble. No
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    te: I am not an attorney. I don't even get to play one on television. If you and your blog deal with some highly controversial issues or you're just not sure how much trouble you would get into if you published that post about your best friend's boyfriend, I recommend getting in touch with a lawyer to get the best advice.

    1. Change the names.
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    By far the easiest thing you can do is to change or to avoid using the name of the person you are talking about and to strip away as much identifying information as possible. If a reasonable person can visit your hometown and quickly identify the 'mealy-mouth cow' you blogged about online, you might want to do some editing.

  • Make use of a disclaimer.
  • 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
    Kevin S Brady has an excellent one on his website. Even something as basic as 'By making use of this blog site, you agree that the opinions expressed are the property and responsibility of their respective owners' may provide some defense in the event of a lawsuit. (Check with a real attor
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ney please).

  • Consider writing your rant as a parody or satire. Extreme exaggerations that no reasonable person would believe are not considered defamation because, quite frankly, they are unbelievable. Be careful though, this type of writing takes a certain je sais quoi, and could easily backfire on you. Have a reasonable person proofread your entry
  • y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    to make sure it passes the believability test.

  • Watch your language. Be sure to use wording that makes it clear that this is your opinion about the subject. Statements like, 'That Mr. Squiggly Toddler Toy is a piece of crap makes it sound as though you are stating a fact when in all actuality you are making a personal judgment about the toy.
  • .

    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
    Something like 'I think that Mr. Squiggly Toddler Toy is a piece of crap' or 'That Mr. Squiggly Toddler Toy fell apart after the first use' are safe bets. At least as far as the law is concerned.

  • And last but definitely not least, don’t tell false tales. Now this may seem like common sense but how common is common sense these days?
  • elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    Really. If you feel the need to resort to lying about a person, you may want to seek professional help in examining why you want to do that. 'Cause chances are, it's not to protect the public.

    Blogging is a great way to meet people and stay current in the world and doing so responsibly will only make the experience better. Stay safe, stay sane and most of have fun


    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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