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You’ve just gotten married, and are traveling the world with your new spouse on your honeymoon. A good friend who filmed the wedding and reception has just finished putting together the footage. He has posted it on YouTube so you both can relive yo

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

ur wedding day on your honeymoon.

The video is wonderful. It illuminates several moments you’d missed in the excitement of the day. Your friend has even included your song, Endless Love, as the background music for the video.
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; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

r>After the honeymoon, as you unpack the doorbell rings. Opening the door you find a man asking for your signature for a package. You think, "Which aunt or uncle must be sending money"? When the deliveryman smiles, hands you the package and says,

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

"You’ve been served." you are surprise and horrified.

Confused, you tear the package open to find a lawsuit for $10,000 for copyright infringement. You wonder to yourself--could this be right? How did I infringe any copyrights? Out o

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

curiosity you scan the pages of the lawsuit for a logical explanation. Then you find it: "the illegal use of Endless Love by Lionel Ritchie and Diana Ross in your wedding video posted on YouTube".

With all the attention YouTube has

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

Combination pro

otten from the Viacom lawsuit for $1 billion for unauthorized distribution and infringe of copyright laws, everyone has overlooked a possible next wave of lawsuits to come. Those are for the vast majority of online videos that are made by small home

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

videographers who have included music in their videos that has not been licensed for use.

Typically music publishers and record labels have turned a blind eye to home and wedding videographers who produce their own work. Shared with an audie

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

ce of usually less then 10 close personal friends and family, these home videographers have all but been ignored for years. This was before sites like You Tube, Google Video, ChickShack, AsSeenInVT and a handful of others began creating an outlet fo

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

r anyone with a video camera. Now home videographers need to be warned. You may soon find yourself involved in lawsuits for illegal use of a copyrighted protected musical recording, the fines for which could be in excess of $15,000 per song.

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

b>Remember how fiercely the recording industry went after everyone from children to old ladies who downloaded songs from sites like Napster? It may be only a matter of time until they start going after videographers in the same manner.
Most h

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

me videographers are unaware of the limitations on using copyright protected music. The vast number of home Videographers wrongly assume that they can synchronize or place any music they want in their video production. In the past, a small home and

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

Following aspects would a

wedding Videographer would usually get away with this. The problem is these wannabee Quentin Tarantino’s have now begun distributing their productions to more then just a few friends and family. A video loaded online has the potential market of hun

dd to the challenges in developing combination products:

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

reds of thousands, or even millions, of viewers, and if you’ve created something popular using YouTube, you may be the next victim.

Local TV stations in America can pay tens of thousands of dollars for licensing music for their stations

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

. This price can go into the millions if they desire to use popular artists songs.

For Videographers who have uploaded productions onto sites like YouTube and are now nervous, let me educate you a bit on how licensing works.

Simply put

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

copyright laws state that any music under copyright protection may not be used for any kind of video production, media presentation, websites, etc--that is, without approval from the copyright owner. Several types of licenses are usually required.

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

These may include some or all of the following: Synchronization, Performance and Master licenses.

Now before you stress over the fact that no one will see your masterpiece or that big the bad RIAA is coming to get you -- there is a solution.

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

Professional from academic institutions, pharmaceutical industries, health care indust

First, you must remove the copyrighted music you have in your videos. Then you have the option to either write your own music for your video (most of us are not musically creative enough to go this route) - or license music from an Online P

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

oduction Music Library.

Online Production Music Libraries typically lease music from their catalogs on either an individual per use basis, called a drop, or blanket licenses that will cover an entire project. The advantages of online producti

.

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

on music libraries are the scope, depth and breadth of the catalogs. Pricing ranges greatly, depending on many variables.

Most production libraries do not create music specifically for amateur videographers, but Recently, an L.A. based prod

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

Companies that provide selfless information through particip

ction music library called TunEdge Music announced it would give special licensing for web distribution. TunEdge Music is providing access to their online catalog and for a reasonable fee their music can be licensed specifically for online creations

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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