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Are you the lucky owner of a lemon?

If you think your car is a lemon, then

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 probably feel like you're always in the repair shop for the same repai

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

Examples of combination products may in

over and over again. Sure the repair is covered under the vehicle warranty

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

or extended warranty, but it's always in the shop!

If it seems your car is

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

in the repair shop time and time again for the same repair, you may be the

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

Combination pro

ucky owner of a lemon. Fortunately, your state has recourse for you, so get

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

started protecting yourself right away.

Both the lemon law and an extended

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

warranty can benefit you when you have purchased a new or used vehicle that

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

appears to have defects that cannot be remedied by repeated repairs.

If yo

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

chose to purchase an extended warranty, know your rights given to you unde

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

the warranty, and be thorough in your inquiries. Be aware that if you deci

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

Following aspects would a

ed to purchase an extended warranty with your vehicle, you may not be cover

dd to the challenges in developing combination products:

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

d by the lemon law in your state.

If you chose not to purchase the warrant

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

, know your rights under the lemon law, and immediately contact a lemon law

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

attorney if you feel your rights have been violated.

And if your car is de

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

ermined to be a lemon, can you legally sell your lemon? Though it may not a

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

Professional from academic institutions, pharmaceutical industries, health care indust

ways be easy to sell your car following a lemon law battle, do not despair.

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

As long as you disclose all pertinent facts, legally you can sell that lem

.

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

n!

Honesty regarding the lemon law is always the best policy, and disclosu

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

Companies that provide selfless information through particip

e makes it legal. Just follow a few simple guidelines and you’ll be alright

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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