United States usage outside th

&Nbsp;  requirements for using the drug registration usage doctor use drug registration when used outside, doctors have a duty to medicines fully understand, the use of drugs to be based on a sound scientific basis and a solid medical evidence, and keep records of the use and effects of drugs.when practice for the purpose of use of medicines (unregistered usage), the doctor does not need to submit research-new drug application (IND) or research device exemption (IDE), does not need the institution Review Board (IRB) for consideration. However, the usage of drugs in use this institution has the right to require the IRB or other institutional supervision. (Originally seen:  http://www.fda.gov/RegulatoryInformation/Guidance/UCM126486.htm) pharmaceutical enterprise publicity registration uses pharmaceutical enterprise of medical literature sent to doctor or medical institutions, publicity when unregistered uses of drug, should meet following principles.on pharmaceutical companies distribute medical scientific journal literature request   ①   published articles of Organization (magazine), the editing Committee must be composed of experts whose members in the article content in the fields of expertise, and ability to independently and objectively select, rejected to submit articles or comments. At the same time, organizations (magazine) should have a public statement of policies, full disclosure of all the article authors and journal editors any conflicts of interest or bias. ②   articles should go through peer review (peer-reviewed), and in accordance with the Organization (Journal) of peer-review procedure. ③   the article should not be in the form of special supplement (Special supplement), and should not, in whole or in part by the Institute of articles involving the financing of drug manufacturers.on unregistered usage of drugs in pharmaceutical company medical scientific literature dissemination requirements ① literature should be the uncut version of the original copy. ② literature should not be drug producers in any way mark, stressed that (some), draw conclusions, and so on. ③ literature and medicine or medical device is approved (register) of labels issued. ④ circulated simultaneously with the literature, there should be a comprehensive bibliography covering involved drugs or equipment-related, and other clinical research literature: a good (if you have this information). ⑤ circulated simultaneously with the literature, there should be a response to drugs or devices this unregistered use of negative or opposite conclusions of the article (if you have this information). ⑥ literature should not be against any publicity for the essence of information (such as pharmaceutical promotional material) at the issue. (Originally see http://www.fda.gov/RegulatoryInformation/Guidance/UCM125126.htm) related links: register usage management and prospect    drugs in China;