Actual - Legal

Legal problems can easily sink your internet business before you even begin to swim. Legal requirements abound in the internet arena. It’s your respon

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

sibility to get yourself up to speed on these requirements. Ignorance of the law is not acceptable.

Links to your Contact Information and All About U

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

Examples of combination products may in

Information should be on all of your webpages. Your main legal information is your Copyright, Terms of Service, Disclaimer, and Privacy Policy and th

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

y should be included as well.

Copyright

Make sure the word copyright and the copyright symbol are at the bottom of your webpages. If you are selling

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

anything, include the words All Rights Reserved. If your product is available worldwide, include that term also.

Terms Of Service

An age statement i

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

Combination pro

strongly advised. In the US, the minimum age is 13 years old, 18 in most other countries. To safeguard yourself, use 18 years old as the required age

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

for your site. Also include the terms for using your site.

Cyberspace has its boundaries. There are rules and regulations that govern advertising. 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

ey are called the Dot Com Disclosures. They can be found here: http://www.ftc.gov/bcp/conline/pubs/buspubs/dotcom/index.html

Disclaimer

The interne

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

is riddled with viruses, spyware, Trojan horses, and all those other attackers of your computer. Tell visitors to take precautions. Are you giving ad

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

ice?

Always let your visitors know they should see a relevant professional before using your advice. Also, due to the fast changing nature of the int

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

rnet, information goes out of date. You cannot be held liable for that, so let your visitors know.

If you sell a product your visitors expect to help

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

Following aspects would a

them make money, never say the amount they should make. Your legal problems will multiply if you do. You really don’t know.

So many variables go int

dd to the challenges in developing combination products:

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

others being as successful as you. The visitor may not have the internet savvy that you have, or the motivation. You can’t guarantee results. Here is

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

where you state all of that information.

Privacy Policy

Should you capture a visitor’s private information, include your policy for doing so. Tell y

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

ur visitor what you intend to do with the information. If you intend to share the captured information, you must say so.

I’ll just add this about spa

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

ming. This is a small area in the Can Spam Act that receives much abuse. It states, “The Act also prohibits false or misleading subject headings in co

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

Professional from academic institutions, pharmaceutical industries, health care indust

mmercial email messages.”

Don’t send any grand promises of fame and fortune in your email subject line. This is generally done to encourage people to

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

open your email.

Build a great relationship with your list. There’s no need for grandstanding. When the people who know you see your name they will o

.

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

en your email. You can take that to the bank! Find spam info here: http://www.ftc.gov/bcp/conline/edcams/spam/rules.htm.

I can’t guarantee that you

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

Companies that provide selfless information through particip

ill not have legal problems during your internet journey. But if you include these items in your website, you would have done much to reduce your risk

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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