{"product_id":"distributing-scientific-and-medical-publications-food-and-drug-administration-9781797810829","title":"Distributing Scientific and Medical Publications on Unapproved New Uses: Recommended Practices for Pharmaceuticals and Medical Devices","description":"This PRINT REPLICA contains the FDA guidance for industry on \u003cb\u003eDistributing Scientific and Medical Publications on Unapproved New Uses dated February 2014\u003c\/b\u003e, and the \u003cb\u003eFood and Drug Administration Modernization Act of 1997.\u003c\/b\u003e \u003cp\u003e\u003c\/p\u003eThis is a revision of the guidance released in 2009 and is intended to clarify the ways in which a medical device manufacturer or pharmaceutical company or may use scientific and medical literature to promote its products, even if the literature doesn't conform to the FDA-approved uses for the product. This is a checklist that companies will need to consult for each instance of scientific and medical literature they wish to promote. These include medical and promotional interactions with health care professionals (HCP), Payer\/Formulary Access Interactions, Publications, Grants And Continuing Medical Education (CME), Investigator Initiated Studies (IIS), and Post-Marketing Studies.\u003cbr\u003eAccording to the Executive Director of the Coalition for Healthcare Communication, John Kamp, \"Manufacturers should be able to distribute truthful information - in the form of journal articles, medical textbooks and practice guidelines.\" \u003cp\u003e\u003c\/p\u003e\u003cb\u003eWhy buy a book you can download for free? We print this book so you don't have to.\u003c\/b\u003e \u003cp\u003e\u003c\/p\u003eFirst you gotta find a good clean (legible) copy and make sure it's the latest version (not always easy). Some documents found on the web are missing some pages or the image quality is so poor, they are difficult to read. We look over each document carefully and replace poor quality images by going back to the original source document. We proof each document to make sure it's all there - including all changes. If you find a good copy, you could print it using a network printer you share with 100 other people (typically its either out of paper or toner). If it's just a 10-page document, no problem, but if it's 250-pages, you will need to punch 3 holes in all those pages and put it in a 3-ring binder. Takes at least an hour. \u003cp\u003e\u003c\/p\u003e\u003cb\u003eIt's much more cost-effective to just order the latest version from Amazon.com\u003c\/b\u003e \u003cp\u003e\u003c\/p\u003eThis book includes original commentary which is copyright material. Note that government documents are in the public domain. We print these large documents as a service so you don't have to. The books are compact, tightly-bound, full-size (8 1\/2 by 11 inches), with large text and glossy covers. 4th Watch Publishing Co. is a HUBZONE SDVOSB. https: \/\/usgovpub.com\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Food and Drug Administration\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1797810820\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781797810829\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Independently Published\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 02\/22\/2019\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 110\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.60lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 11.00h x 8.50w x 0.23d","brand":"Food and Drug Administration","offers":[{"title":"Paperback","offer_id":48113730420991,"sku":"9781797810829","price":26.1,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_a1d86f2d-de85-4734-8b57-9d6bf6ff90e0.jpg?v=1769616939","url":"https:\/\/www.whiterainbookhouse.com\/products\/distributing-scientific-and-medical-publications-food-and-drug-administration-9781797810829","provider":"WR Book House","version":"1.0","type":"link"}