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Actual - Keep Your Disability Claim Going
As much as they would want to prevent it, dedicated and hardworking citizens can not control situations leading to their demise or disability. Disability becomes
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
the consequence of illness or accidents in or out of their workplace. Being disabled, one can not anymore perform their present job or any other kind of jobs, a
; 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
ymore.
As a government service to workers inflicted with disability, the Social Security Act provides the Social Security Disability Insurance and Supplemental
As a government service to workers inflicted with disability, the Social Security Act provides the Social Security Disability Insurance and Supplemental
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ecurity Income (SSI) programs. As compensation for the loss of income by the disabled worker, they can file for disability claims under these programs.
However,
However,
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
many of those who filed their disability insurance claims fall victim into believing that everything would go smoothly and that nothing will mar their claim for
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
benefits. It is important to be enlightened with the hard facts regarding this matter so as to prevent bitter disappointments during the process.
First of all,
First of all,
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 aware that the process of securing claims is not a walk in the park. It is a long and constant follow-up. Few claimants are ever enlightened of this fact upon
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
filing for their Social Security disability benefits. There are certain levels in processing of claims, the initial level and the reconsideration level.
Accordi
Accordi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
g to statistics, 60 – 70% of disability claims at the initial level are denied. Many have experienced receiving in their first notification letters from the Soci
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
l Security Administration (SSA) that their claims have been denied. Meanwhile, up to 80 – 85% of the claims in the reconsideration level are denied. With this, t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e social security disability benefit claims takes up to two or more years.
Having these facts in mind, how can one keep their disability claim going?
First of
Having these facts in mind, how can one keep their disability claim going?
First of
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
all, for those who find that their case is denied, remember that panicking and brooding about it will not help any. This is not a personal failure since almost a
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
l of the claimants experience this. As long as you have your medical records intact and know that your impairments are serious, do not ever give up nor hesitate
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
n filing for an appeal. This is a necessary process and filing a brand new claim should never be an option.
As soon as you received the notification letter expr
As soon as you received the notification letter expr
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
essing denial of your claim, immediately request for an appeal. A grace period of 60 days is given for those who wanted to appeal their claim. Express the appeal
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
by requesting for reconsideration. This should be done personally so that the request will become an official record at the SSA office where the initial claim wa
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
filed.
Failure to file for appeal within 60 days will result to losing appeal rights. It is tedious to start at the very beginning again, which involves the fi
Failure to file for appeal within 60 days will result to losing appeal rights. It is tedious to start at the very beginning again, which involves the fi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ling of a new Social Security Disability or SSI application and most probably, waiting out just to get another denied case.
Once the disability claim has been f
Once the disability claim has been f
.
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
led, it is necessary to keep on going, even if the initial level and reconsideration level of the case turns out to be denied. Establish a constant contact with
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
he SSA office where the claim is filed. Getting the advice and guidance of a social security law attorney or even non-attorney representative may also be helpful
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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