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Many wounded returning Iraq War Veterans are not being advised well about filing their VA claims for benefit

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

s. Most of the time, the only assistance the veteran receives is one printed sheet that they get during the

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

Examples of combination products may in

discharge process that tells them to get on the VA website and to file their claim electronically. If an Ira

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

veteran has been wounded with a permanently disabling injury, the veteran needs to file a claim.

Unfortuna

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

tely, returning vets with PTSD (post traumatic stress syndrome) are often mentally unable to complete the fo

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

Combination pro

ms needed to file a claim. Their stress levels leave them unable to concentrate on the task of completing th

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

e forms, gathering documents needed, and stating the cause of their PTSD. Simply writing down the events fre

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

uently leaves them so stressed and anxious that they are unable to function on a daily basis. Ironically, th

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

ese veterans need help with their PTSD as soon as possible.

Vietnam veterans fought the VA to be acknowledg

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

d as disabled with PTSD. PTSD is nothing new. In wars past, it was called “shell-shock” (World War I) and “c

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

ombat fatigue” or a “nervous condition” (World War II).

Gulf War veterans, too, have “undiagnosed” problems

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

Following aspects would a

with aches and pains and odd symptoms that doctors are unable to put their finger on to treat. These vetera

dd to the challenges in developing combination products:

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

s, too, need to file VA claims. Their problems are caused by exposure to harmful chemicals and gases that we

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

re used by both sides fighting in the Gulf.

Returning Iraq War veterans that have permanent injuries, burns

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

scars or other problems from combat are advised to file VA claims. Scars, especially on the face, are consi

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

dered “disfiguring” and are worthy of a disability rating by the VA.

Even if a disability is rated at zero-

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

Professional from academic institutions, pharmaceutical industries, health care indust

ercent disabling by the VA, it is important for these young veterans to have the disability acknowledged by

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

the VA. As a person ages, disabilities that seem very tolerable at 25 years of age become arthritic and pain

.

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

ul to a person at 50 years of age. The disability can be re-rated at a later date and it is much easier to h

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

Companies that provide selfless information through particip

ave a disability re-rated at a higher rating than to try to establish the disabilty 30 years after discharge

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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