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Answers - The Green Card Interview At the INS
Before your wife is issued a Green Card or given permanent residency, you both will have to attend a Green Card interview by an INS officer.
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
You will be notified of the date of your interview weeks in advance. Your INS interviewer will have your complete file in front of him or her
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
and will have reviewed it by the time your interview has arrived.
Our interview went very smooth. The INS officer asked similar questions abo
Our interview went very smooth. The INS officer asked similar questions abo
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ut how we met, how long we’ve known each other, et cetera, that we had at the US embassy when applying for our fianc? visa.
The purpose of th
The purpose of th
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 interview is to determine the legitimacy of our relationship and my wife’s claim for permanent residency.
The interview is videotaped. Whil
The interview is videotaped. Whil
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
you may be nervous, just answer the questions. Don’t volunteer any information. This is similar to a police investigation in that any informa
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
tion can and will be used against you.
But remember, your relationship is legitimate. You are innocent. You have nothing to hide. Just answer
But remember, your relationship is legitimate. You are innocent. You have nothing to hide. Just answer
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
the questions asked in as direct a method as possible.
You Have The Right To Appeal:
I have heard stories of people who have had a difficul
You Have The Right To Appeal:
I have heard stories of people who have had a difficul
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
t time at the interview. According to the couples reporting the stories, the INS officer was rude and condescending and stated that they did n
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
ot believe that they had a legitimate marriage.
We had the opposite experience. However, be prepared for some tough questioning. Even if the
We had the opposite experience. However, be prepared for some tough questioning. Even if the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
NS officer is not having the best day, maintain your composure and answer the questions that are asked.
If your petition is legitimate, you s
If your petition is legitimate, you s
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
houldn’t have any problems. Your application will be approved.
If, for some reason, your application is denied, you can appeal. You can get t
If, for some reason, your application is denied, you can appeal. You can get t
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
he immigration attorney who filed your Fianc? Visa to help you in the matter.
You will find out whether your application is approved at the i
You will find out whether your application is approved at the i
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
nterview. Your wife’s Green Card may arrive several weeks later or several months later.
Properly Secure Her Green Card:
Do not lose your Gr
Properly Secure Her Green Card:
Do not lose your Gr
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
een Card. Make copies of it. Whenever your wife leaves the country, make sure she carries her Green Card with her, plus copies of it, in case
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
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
t gets lost.
She will not be readmitted to the United States without the Green Card in her hands when she arrives.
The Green Card she will r
She will not be readmitted to the United States without the Green Card in her hands when she arrives.
The Green Card she will r
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
eceive is a special two-year Green Card. Just in case she got married for the sole purpose of getting a Green Card, the INS issues the two-yea
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
r card.
At the end of two years, her Green Card expires. If she is not married to you at that time, her Permanent Residency may expire. She h
At the end of two years, her Green Card expires. If she is not married to you at that time, her Permanent Residency may expire. She h
.
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
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
as the burden of proof to show why she should get a new Permanent Residency card.
Of course, if she is still married to you at the end of two
Of course, if she is still married to you at the end of two
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
years, she must re-apply for a new Green Card, which she will automatically be granted. This new Green Card will be for ten years in duration
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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