Answers - Legal

There’s no doubt that it’s easier to register your photographs before you pu

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

blish them. But if you didn't get it done then, it's better late than never

; 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 register your published images. The good news is that it’s more convenien

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

t and cheaper than ever to register your photographs after they have been pu

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

blished.

Pursuant to a recent change in copyright law, you now can register

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

Combination pro

a group of published images on one form. The only requirements are that the

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

photos must have been published in the same year, made by the same photograp

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

her and have the same copyright claimant. This should fit the profile of mos

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

t photographers and their work.

Another beneficial change in the law is tha

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

t group registration of published images currently requires only one “deposi

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

” or copy of the image. Previously, you had to submit two of the actual publ

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

Following aspects would a

ished copies. Now you can register your published images on one form, with o

dd to the challenges in developing combination products:

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

nly one deposit, one application and one filing fee, as long as they meet th

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

e above requirements.

Specific instructions on how to prepare your registra

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

tion forms for published photographs are available from the Picture Archive

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

ouncil of America at http://www.pacaoffice.org/copyright.html in “The Import

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

Professional from academic institutions, pharmaceutical industries, health care indust

ance of Copyright Registration”

You no longer have an excuse. Go to the den

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

tist, change the oil in your car, and register your images, both unpublished

.

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

and published. It’s better late than never.

Take my advice; get profession

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

Companies that provide selfless information through particip

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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Answers - Better Late Than Never - Register Your Published Photographs

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