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If you drive a commercial vehicle (big rig, delivery truck, bus, etc.) in C

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

alifornia you should be aware there are certain legal requirements for vehi

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

Examples of combination products may in

cle insurance that you must maintain. Because commercial vehicles can ofte

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

n carry hazardous materials or precious cargo (such as our children) the in

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

surance requirements for them are much higher than traditional automobile c

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

Combination pro

overage.

Not all insurance companies offer commercial vehicle insurance.

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

Some companies that specialize in auto coverage have a separate division th

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

t handles heavy vehicle insurance underwriting. Many times you can consult

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

with your agent who can inform you of their coverage availability or refer

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

you to another insurer who may be able to handle your commercial needs.

S

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

ome of the requirements for getting coverage of these larger vehicles can i

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

Following aspects would a

nclude specialized driver training requirements as defined by the state of

dd to the challenges in developing combination products:

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

CA. Often drivers must have a special endorsement or license to drive such

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

vehicles. Regular inspections are usually mandatory for such vehicles as

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

ell to help maintain safety on the road. It is not uncommon to see random

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

inspection points setup across the state to do spot checks of commercial tr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ucks and other vehicles.

If you have any questions about the availability

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

of coverage or the minimum requirements necessary you should contact the st

.

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

ate department of motor vehicles who will explain detailed coverage require

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

Companies that provide selfless information through particip

ments based on the type of vehicle and for what purpose it will be used for

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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