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Sailing off into the blue yonder, has the salutary effect of blowing cares and stresses away with the winds. However, before you sail away in

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

your new boat, consider the merits of these questions. Do you have boat insurance? Moreover, are your insurance needs fully met?

Marine insur

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

Examples of combination products may in

ance defines vessels according certain measurements. A boat is defined as one measured between 16 feet and 25 feet, 11 inches in length. If 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’s the length and width of your seaworthy vessel, then you have a boat.

Here are the pertinent components your boat insurance policy should

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

have:

Physical Damage Coverage

The insurer pays you for the repair or replacement of your boat, under the following circumstances: Theft, v

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

Combination pro

andalism, lightning, fire, tornadoes, or hurricanes. Included in this coverage is the boat itself, outboard motors, engines, and your boat tra

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

iler.

Excluded from the coverage are the following items, which are not, considered a part of your boat’s operations: camera or video equipme

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

nt, clothing, fashion accessories, or jewelries, food or beverages, cell phones, stereo equipment, portable television, personal computers or

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

scuba gear. Alternatively, you can ask for separate coverage for these items.

Tip. Read the fine print and so that you know what restrictions

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

could apply to your coverage. Can your boat be stored at your place of residence? Alternatively, should the boat be at your vacation spot? Wh

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

ere does the coverage begin? Some policies specifically limit the uses of your boat and list the exceptions.

Liability Coverage

You’ll find

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

Following aspects would a

this coverage quite useful. You may also wish you‘d paid a bigger premium, when there’s an accident and your boat is liable for damaging anoth

dd to the challenges in developing combination products:

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

er boat, property, or injury.

Uninsured Boat Coverage

This is the marine insurance equivalent of the road vehicle’s uninsured motorist cover

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

age. In this case, your boat’s repairs are covered, in the event the owner of the property your boat collided with has expired insurance or wo

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

rse, doesn’t have it.

Passenger Medical Coverage

This coverage pays for the medical expenses incurred by people on your boat. This is a must

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

-have clause and the limit can be inexpensive, from $450.00 to $10,000.00, is quite common.

Towing & Assistance Coverage

With this coverage,

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

Professional from academic institutions, pharmaceutical industries, health care indust

you’ll get reimbursement for the costs you’ve incurred for availing of emergency services. Examples of these, your vessel breaks down, and a

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

commercial outfit tows your vessel to the port, you’ve paid for delivery to replace your fuel, oil, or engine parts, or for someone to repair

.

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

your engine.

The bottom line to all this? Be pro-active and arm yourself with knowledge, which among the different policies possible, your bo

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

Companies that provide selfless information through particip

at insurance should have.

Then, you’ll sail confidently into the sun, because your insurance policy will cover you where it’s most necessary

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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