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Since Amazon.com acquired Mobipocket in April 2005, the online bookseller has made some dramatic changes to its ebook strategy. Publishers and authors used to be required to set up an account with Lightning Sou

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

rce to list ebooks with Amazon, but now ebooks are managed by Mobipocket.

To complicate matters further, the ebook version of a title is no longer listed with its print version. In fact, Amazon no longer index

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

s ebooks on its site at all. When you browse Amazon’s book categories and click on “ebooks,” you are directed to a link that takes you out of Amazon.com and onto Mobipocket.com. The reality is that ebooks are n

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

longer actually sold on Amazon.com at all, but directly through its subsidiary.

There is a debate brewing on blogs across cyberspace about this controversial strategy since many consumers prefer the old metho

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

of purchasing ebooks directly from Amazon. But unless Amazon decides to change its strategy again, publishers and authors must follow the new policy to list their ebooks for sale.

Amazon would like to manage

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

he process of approving ebook publishers and asks publishers to send an email to digitalrights@amazon.com with the following information:

*What publishing company do you represent? (If you are the author, ple

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

ase enter “author” and the name of the publishing company you work with)

*Your contact information:

Name:
Professional title:
Business address:
Email address:
Phone number:

*Please

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

list the ISBNs of the books you are considering making available as eBooks:

*For these titles listed, do you own the digital rights (rights to sell books in a digital format)?

Several days after receipt of th

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

s information, Amazon will send you an email with further instructions for registering a publisher account with Mobipocket. But you can jump ahead in the process by following these steps:

1. Register your publ

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

sher account:
http://www.mobipocket.com/eBookBase/en/Homepage/apply.asp?Type=Publisher

2. Review and sign the publisher agreement:
http://www.mobipocket.com/eBookBase/en/Homepage/pub_agreement.asp

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

. Fax the agreement back to Mobipocket in France at 33 148 25 90 07. According to the digital rights staff at Amazon, this is the only method that is available for returning signed agreements (they won’t accept

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

Following aspects would a

agreements via email). Following receipt of your signed agreement, Mobipocket will send you an email with an account login and password.

4. While you wait for your login information, you can convert you ebook

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

to Mobipocket format. Download the free conversion software at: http://www.mobipocket.com/en/DownloadSoft/ProductDetailsCreator.asp?edition=Publisher.

The program can convert MS Word, text or PDF documents. B

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

sure to examine your newly created ebook with Mobipocket’s preview tool since the formatting does not always convert correctly. You may need to make some adjustments to text spacing or font sizes.

5. As soon

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

s you receive your login information for your publisher account, you can manage your publisher account at http://www.mobipocket.com/ebookbase/en/homepage/Logon.asp

This is where you will upload your ebook and

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

et your desired retail price. Keep in mind that Mobipocket retains 50% of the retail price as their royalty payment. You will also give up another 10% of the price if you allow affiliate sales.

6. Once you hav

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

Professional from academic institutions, pharmaceutical industries, health care indust

e verified that the ebook looks good and your price is set, you must choose to activate the file. This process makes the ebook available to buyers at Mobipocket.com and through their network of partners. Conver

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ely, if you want to remove your ebook from Mobipocket’s catalog, you can deselect the “activate” option.

Though many of us would like the ability to submit ebooks in PDF format, as well as see ebook titles lis

.

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

ed with their print counterparts on Amazon, for now we can only hope that Amazon modifies its process in the near future. In the meantime, the Mobipocket publisher account costs nothing to implement and the lis

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

Companies that provide selfless information through particip

ing process, though tedious, is relatively easy to complete. Perhaps with Mobipocket’s network of partners, the extra effort will be worthwhile when it comes time to receive royalty payments for our ebook sales

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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