Actual - Legal

If you are trying to register any type of performing art you should follow the copyright proce

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

ss as explained here. Performing arts can generally be described as any artistic work intended

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

Examples of combination products may in

to be “performed” directly in front of an audience or indirectly “by means of a device or pro

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

cess”. This includes motion pictures, audiovisual presentations, dramatic works in script form

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

including accompanying music and musical works with accompanying words. The phrase above “int

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

Combination pro

ended to be performed” is crucial in determining whether to register as a performing art or as

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

a sound recording. If you register the words and music as a performing art you are protected,

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

but if you record a performance of the song you must then register that performance as a soun

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

d recording. If you fall within this category you should register for a performing arts copyr

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

ight.

The second step is to put together a package including either a form PA or short form P

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

, a check for $30 made out to the “Register of Copyrights” and a non-returnable copy of the ma

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

Following aspects would a

terials that are being registered. The form PA and short form PA can be obtained at the copyri

dd to the challenges in developing combination products:

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

ght offices website at http://www.copyright.g

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

ov under the performing arts tab. If you are registering a musical work or a motion pictur

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

e you will be required to deposit one copy of the recording and a copy of the music or shootin

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

g script in this package.

Finally address the package to…

Library of Congress
Copyright

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

Professional from academic institutions, pharmaceutical industries, health care indust

Office
101 Independence Avenue, S.E.
Washington, D.C.20559-6000

As soon as the cop

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

yright office receives your package and confirms that it has been received in proper order you

.

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

r copyright is considered to be in effect. You will receive written confirmation in the mail s

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

Companies that provide selfless information through particip

hortly thereafter. They will contact you with details if something is missing or out of place

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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