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I'll E-mail You... There are truly very few of us living today that have not read, written or forwarded e-mails to someone. E-mail has become an integrated part of our information-overload

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

ed lives offering immediate gratification whether to inform, or to be informed.

As all communications require both a sender and a receiver, there are continuous opportunities for misunder

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

Examples of combination products may in

tanding and annoyance. Due to the speed and efficiency of e-mail, these aggravations can be magnified quite rapidly as anyone who receives scores of unwanted messages per day can attest. I

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

n an effort to contribute something to world peace, the following tips for sending, receiving and general handling of e-mail may help to calm our lives just a bit.

First of all, e-mail is

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

not the end-all communications method. Telephone, telefax, and tell-your- Mom are all still tried and true means of effective communication as well as some newer varieties like web-logs, w

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

Combination pro

b-boards, instant messages, text messages and the like. We have choices to fit all lifestyles (and budgets) intents and purposes. But as with nutrition, too much of any one thing is not he

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

althy, and we should strive for balance. Voice communication offers intonation, face-to-face communications add expression and body language, and the hand-written letter a sense of care, t

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

ought and deliberation. E-mail today holds a primary position for immediacy and completeness with the ability to attach photos, documents, imbed animation, links, and virtually infinite am

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

ounts of information.

Tips for receiving e-mail: 1. Safeguard your e-mail address. If you shop or otherwise spend time on the internet and provide your e-mail address, it can be used to b

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

ild databases and automatically generate e-mails to you both wanted and un-wanted. Establish a free e-mail address at Yahoo, MSN or similar service to use for online activity, saving your

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

rimary e-mail address for your important communications. 2. Don't open attachments from people you don't recognize. These can carry malicious elements such as viruses which can bring your

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

Following aspects would a

computer to a screeching halt as well as pass the favor on to others without your knowledge. If uncertain, use one of the other communications methods mentioned above to verify the legitim

dd to the challenges in developing combination products:

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

cy of the attachment.

Replying do's and don'ts: 1. Know who you are replying to. Sounds simple, but there are countless stories of forwarded e-mails ending up in unintended hands due to c

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

areless forwarding, or miss-typed e-mail addresses. Note on the received e-mail if there are others copied, and make sure you know if your reply is going to the originator or all original

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

ecipients. 2. Use your e-mail program to store an address book to avoid miss-typing addresses and help anti-spam programs filter out unsolicited mail. 3. Avoid volleying to clarify persona

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

conflict, emotional, or other sensitive issues. Remembering the lack of intonation, body language and other clues to intent, it is easy to miss the point when emotions are at stake. Pick

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

Professional from academic institutions, pharmaceutical industries, health care indust

up the phone, or go see the person to clarify. 4. Don't hide behind replies as "action passed". It is often too easy to forward an e-mail and think that action passed is action completed.

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

Writing tips: 1. Be brief. 2. Don't use all capital letters in a message. It is rude. 3. Consider your recipient in terms of time, attitudes, and technology. If your recipient has a dial-u

.

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

p modem, don't send large photos or otherwise difficult messages to receive. 4. Keep it clean. 4. Remember e-mails are permanent records. They can not be thrown in the fireplace and destro

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

Companies that provide selfless information through particip

ed forever. Electronic copies exist in multiple places making it virtually impossible to erase all instances and history.

Now have at it and enjoy e-mailing with more confidence and peace

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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