Answers - Legal

Our highways accommodate millions of passenger vehicles, buses trucks, and tractor-trailers. These extremely large semi trucks carry essential products, parts, livestock, and equipment for busi

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

ness and consumers. Economically we need these big trucks, but sharing the road with them can be very dangerous. When driving near a tractor trailer be alert and take extra safety precautions.

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

Examples of combination products may in

Know the Risks:

Most states allow extremely large trucks and tractor-trailers to travel on major highways. The following are some of the current legal standards for semi tru

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

ks, tractor-trailers, and other large trucks:

A loaded tractor-trailer can be up to 8 1/2 feet wide -- 50% wider that a passenger car. (102 inches)
The overall length of a truck

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

hauling a trailer can be up to 65 feet on designated truck routes.

The length of a tractor-trailer transporting logs can be up to 70 feet, or more than 4 times the length of an average

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

Combination pro

utomobile.

There is no overall limit on the length of a semi truck, if it is pulling one trailer no longer than 50 feet or two trailers no longer than 28 ? feet each.

The normal

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

maximum load for a truck with a single trailer can be as much as 80,000 pounds. A few states, including Michigan, allow trailers with multiple axles and tires to haul up to 120,000. Watch for t

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

hese trucks which usually carry steel, gravel, heavy equipment, asphalt, and other extremely heavy goods.

The maximum weight of a tractor truck with two loaded trailers can be as much

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

s 160,000 pounds, about the same weight as 50 passenger cars.

The enormous size and weight of a tractor-trailer make it a potentially dangerous vehicle, even if a skilled and carefu

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 truck driver is at the wheel.

Safety Tips for Auto Drivers Sharing the Road with Large Trucks

If you are on the highway near a tractor trailer or semi truck, you can reduce

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

he risk of a serious accident by driving with extra care. Here are safety guidelines to help you protect yourself and your family:

Stay out of truck blind spots. Althou

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

Following aspects would a

gh every truck has side mirrors, the driver still has blind spots--areas directly behind and on both sides of the truck where the driver cannot see cars. Look at the truck, if you can't see the

dd to the challenges in developing combination products:

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

driver's side view mirrors, you are in the blind spot and the driver can't see you. If your car is next to a large truck, either drive on past or back off. If you are passing, try to drive you

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

car on the left side where the blind spot is smaller.

Never follow a large truck too closely. Keep 20 to 25 car lengths between the front of your vehicle and t

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

he back of a large truck. This extra distance will allow you to see in front of the truck. In case there is congested traffic or an accident up ahead, you will see it in time to stop or safely s

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

eer your car away from the danger.

Use extra caution when passing a large truck. After you pass a large truck, do not pull your car back into its traffic lane u

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

Professional from academic institutions, pharmaceutical industries, health care indust

ntil you can see its headlights in your rear view mirror. Leaving this extra distance gives the truck driver the time to slow down or stop if something is happening on the highway ahead.

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

Always remember that a loaded tractor-trailer or semi truck needs as much as 100 yards -- the length of a football field -- to come to a complete stop. No matter how c

.

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

owded the highway, make sure to maintain this safe distance. If the truck driver ignores this margin of safety and follows your car too closely, do not take a chance. Move your car into another

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

Companies that provide selfless information through particip

traffic lane.

Always use your turn signals when changing lanes. Drivers around you need to know what you are doing to maintain safe driving distances.

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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