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California like the rest of the country has many non-English or limited English speaking residents particularly within the Latino population. To capture these markets many companies

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

often employ bilingual individuals. Sometimes these bilingual individuals chose to take advantage of the limited English speaking for greater profitability to the business and to l

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

Examples of combination products may in

ine their own pockets. While limited English speaking customers may seem like easy targets, California law provides for tough sanctions and expansive protection of these customers.

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

Under California law any person engaged in a trade or business who negotiates primarily in Spanish, Chinese, Tagalog, Vietnamese, or Korean, orally or in writing, are required to d

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

eliver to the other party to the contract or agreement and prior to the execution, a translation of the contract or agreement in the language in which the contract or agreement was n

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

Combination pro

gotiated, which includes a translation of every term and condition in that contract or agreement, among other types of goods and services , this is true if entering into one of the f

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

ollowing contracts:

(1) Retail installment sales, defined as the sale of goods or furnishing of services by a retail seller to a retail buyer for a deferred payment price payable in

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

installments;

(2) a loan or extension of credit secured other than by real property, or unsecured, for use primarily for personal, family or household purposes;

(3) a lease, suble

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

ase, rental contract or agreement, or other term of tenancy contract or agreement, for a period of longer than one month, covering a dwelling, an apartment, or mobilehome, or other d

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

welling unit normally occupied as a residence.

(4) A contract or agreement, containing a statement of fees or charges, entered into for the purpose obtaining legal services, when th

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

person who is engaged in business is currently licensed attorney.

In a recent case in imperial county, (Alba Graciano v. Robinson Ford Sales, Inc., Superior Ct. Case No. L-01452)

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

Following aspects would a

a non-English speaking person bought a car from a car dealer. The salesman apparently attempted to take advantage of the buyer and the buyer proved in court that the deal was for 0%

dd to the challenges in developing combination products:

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

interest loan on a $12,000 car. The documents were prepared in English with no Spanish translation and the salesman increased the price to $17,865.00. The car buyer filed a lawsui

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

t for violation of consumer laws. The jury made a modes award and was to decide on punishment, but a settlement was reached with the buyer for $45,000.00, but the court still had to

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

award attorney fees and costs which were at $249,365.36. The court reduced the attorney fees to $27,570, but on appeal the Court or Appeal held that the attorney fees cannot be red

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

ced, because it would be going against the intent of the legislature which is to protect consumers. On top of approximately $235,000.00 in attorney fees the Court of Appeal also ord

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

Professional from academic institutions, pharmaceutical industries, health care indust

ered payment of the costs and attorney fees associated with the appeal itself. One salesman's error over a $17,865 care cost the dealer about $300,000.

There is an exception for p

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

ersons engaged in a trade or business who negotiate primarily in a language other than English, but has his or her own interpreter. To qualify for the exception the interpreter must

.

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

not be a minor and must be able to speak and read fluently with full understanding both English and the other language.

If failure to comply the person aggrieved may rescind the co

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

Companies that provide selfless information through particip

ntract or agreement in the manner provided by California law. In addition to these remedies other remedies may also apply depending on the goods and services and applicable statutes

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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