Advice Pool - Legal

If you purchased a defective boat that is covered by a warranty, you are

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

protected by the same laws that cover cars, bikes, RVs, computers and man

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

Examples of combination products may in

other items in California – the California Boat Lemon Law. This means th

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

at sellers are discouraged from selling boats that will break down soon a

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

ter purchase. the California Boat Lemon Law is considered a form of fraud

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

Combination pro

protection.

It is important to retain the bill of sale from a seller whe

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

n buying a boat. This holds true even if the boat is secondhand. If the b

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

at is used, you should also obtain an evaluation statement by a qualified

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

expert. A good mechanic should check out the engine, the hull’s integrit

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

and other aspects important to a boat.

The statement the mechanic gives

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

you after this ‘diagnosis’ should outline the condition of the boat at th

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

Following aspects would a

e time of purchase. The owner owner should give you a written assurance t

dd to the challenges in developing combination products:

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

at the boat is seaworthy and will not develop serious problems within a c

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

ertain period of time. This period can be mutually agreed upon.

You cann

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

t exercise ‘lemon’ rights for a boat if you bought it without having its

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

efects highlighted. This will release the seller from any responsibility

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

Professional from academic institutions, pharmaceutical industries, health care indust

by what is legally called ‘caveat emptor’ – you have bought the boat with

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

all present and future defects.

If the boat is new, it should come with

.

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

a warranty that includes a money-back option. If it is a replacement/repa

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

Companies that provide selfless information through particip

r-only warranty, you may have no recourse but to settle for another lemon

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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