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The green card (United States Permanent Resident Card) is something the whole world is going crazy about for years and years now. What it basically does is, give you US Citi

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

zenship. Yes, you become a proud citizen of the United States of America with a green card. To obtain one, you can follow different methods. We will go through them but firs

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

Examples of combination products may in

t, a little history.

The green card is named after a document called "I-151" which was being used in the post-World War II years for the immigrants. Since then the color of

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

the document changed variously, and today even the card is somewhat yellow, the name green card is still being used to refer to the document.

To apply for a green card, on

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

e goes through a 3-step process.

Step 1 - Approval of petition: The application for a green card is approved by the USCIS. There are various criteria for approval depending

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

Combination pro

on the applicant's home country. Except on some rare circumstances, the applicant must have a relative or an employer to qualify for the applicant.

Step 2 - Immigrant Visa

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

Number: An immigrant visa number must be available for the process to continue. There's a problem here: the number of immigrant visas are limited every year, and they are di

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

stributed between all the countries so some countries have a larger number available for them. So this can take long. Very long. The exception is, if you have an immediate r

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

lative (parents, brother, sister, or children over 21) who is a US citizen. Then you're not subject to this.

Step 3 - Adjustment of Status: After the visa number is availab

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

le, the immigrant has to go to the USCIS or his local US Embassy to adjust his citizen status and become a permanent resident of the US.

There are different methods of appl

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

cation. First is family sponsored application, which is basically "if you have family in US, you probably can become a citizen faster than anyone else".

Second method is Em

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

Following aspects would a

ployment Based application. If you are a highly qualified professional, and an employer in the US really needs "you" to perform a specific task in his company, then you have

dd to the challenges in developing combination products:

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

a good chance of becoming a US resident in 6 months or less.

And the last method is the green card lottery.

The lottery takes place every year and a number of people are

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

dmitted from countries from which there were fewer than 50.000 immigrants to US the year before. To enter the lottery you have to fill out an official document that you can

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

obtain from the US Embassy in your region. The guidelines for the document are very hard to follow and if you do anything wrong, you even can't enter the lottery!

An easier

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

way is to find a green card lottery mediator on the internet and apply to the lottery through them. The process is simple: You fill out an online form, they send you a docum

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

Professional from academic institutions, pharmaceutical industries, health care indust

ent with your information on it, you sign it, put a couple of head shots in the envelope and send it back. They take care of the rest.

But beware, there are a lot of scamm

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

ers around. They tell you that they increase the chance to win the lottery, that's not possible. They increase the chance -okay, make sure- that your application is "valid".

.

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

That's all.

There are other, bigger scammers who do not send your application at all too. A quick search over the net with the name of the green card mediator company will

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

Companies that provide selfless information through particip

reveal what they really are.

So in conclusion, becoming a US citizen is not very easy. But you can obtain an immigrant visa if you have the skills and the patience to do so

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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