; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Riot or civil commotion
Damage caused by aircraft
Damage caused by vehicles
Smoke
Vandalism or malicious mischief
Theft
Volcanic eruption
Falling object
Weight of ice, snow, or sleet
Accidental discharge or overflow of water or steam from within a plumbing, heating, air conditioning, or automatic fire-protective slude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
rinkler system, or from a household appliance.
Sudden and accidental tearing apart, cracking, burning, or bulging of a steam or hot water heating system, an air conditioning or automatic fire-protective system
Freezing of a plumbing, heating, air conditioning or automatic, fire-protective sprinkler system, or of a household appliance
Sudden and accidental damage from arthere is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ficially generated electrical current (does not include loss to a tube, transistor, or similar electronic component)
WHAT IS YOUR HOME/HOUSE/RESIDENCE:
This is the actual house that you live in, other buildings such as garage or tool shed, and land located at the address that you are insuring.
WHAT IS YOUR PERSONAL PROPERTY:
This is the contents such as furniture, TV, c
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
othing, jewelry and other belongings that are located inside your home or detached buildings on your property.
If you OWN your home, you also should buy liability insurance:
WHAT IS LIABILITY INSURANCE:
This will protect you if someone is injured on your property or your dog bites someone or eats a neighbors favorite flowers and the situation becomes a “legal issue” where you
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
need help defending yourself or paying for the other person’s medical bills or for repair of their personal property.
DO YOU WANT ACV (ACTUAL CASH VALUE) OR REPLACEMENT COST?
WHAT IS ACTUAL CASH VALUE (ACV):
This payment is the depreciated value of each item at the time it is damaged, destroyed, or stolen. Most policies pay for losses to your contents on an actual cash value basis.
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
Actual Cash Value is an item’s replacement cost minus depreciation.)
WHAT IS DEPRECIATION:
This is the decrease in home or property value due to age or wear and tear since it was built or purchased.
WHAT IS REPLACEMENT COST VALUE (RCV):
This means that brand-new items would be bought to replace or repair your home and/or its contents.
In order to get the replacement cost coverage
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
usually, you must insure your home for at least 80% of what it would cost to build the home at today’s prices. This coverage is not available on all policies.
NOTE:
Coverage on your contents is usually limited to 50 – 70% of the coverage on your home. (If your home is covered up to $100,000, then your contents coverage limit is $50 - 70,000.) The cost for replacement cost coverage is usua
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
ly higher; but in most cases, the extra protection is worth it.
Insurance companies generally want proof you replaced an item before paying your claim in full. The company might choose to replace the items instead of paying cash, the choice is the companies.
WHAT ARE THE BASIC TYPES OF HOME INSURANCE POLICIES|:
HO-1: This is the basic or “bare bones” homeowner policy that covers you
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
house and possessions against the first 10 perils listed above.. This policy is no longer available in most states. Coverage to Building and Contents is ACV
HO-2: This is the broad homeowners policy that covers your house and your belongings against all 16 perils. (It costs about 5% to 10% more than an HO-1 policy) There is a version of HO-2 designed for mobile homes also. Coverage to Build
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
ing and Contents is ACV.
HO-3: This most popular policy is a special homeowners policy that covers all perils except: flood, earthquake, war, nuclear accident, landslide, mudslide, sinkhole and others specified in your policy. Check your policy for a complete list of perils that are excluded. You may be able to buy additional coverage to cover some of the excluded perils. Coverage to the Bu
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
lding is RCV and to the Contents is ACV.
Interesting Note: Floods, earthquakes and poor maintenance cause the most significant damages. You must buy two separate policies for flood and earthquake coverage. Maintenance-related problems are your responsibility, not the insurance company’s responsibility.
HO-4: This is a policy created specifically for those who rent the home they live
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
n. It protects your possessions and any parts of the apartment that you own, such as new kitchen cabinets that you install, against all 16 disasters or perils. This policy covers liability and additional living expenses Coverage is on an ACV basis but may be endorsed to make it RCV.
HO-5: This is an extensive homeowners policy. It covers damage from practically everything except earthquakes
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
wars and floods. Coverage for Building and Contents is on an RCV basis and is the broadest coverage that can be purchased.
HO-6: This policy is for owners of co-ops or condominiums. It provides personal property coverage, liability coverage and specific coverage of improvements that you have made to your unit, and the structural parts of the building that you own against all 16 disasters. (
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
nsurance provided by the owner’s association normally covers most of the actual building.) The limited amount of Building coverage is ACV and Contents is ACV and can be endorsed to make it RCV.
HO-8: This policy is for older homes. It covers the same perils as HO-1 but pays only for repair costs or actual cash value, since replacement cost could make the policy costly. Coverage to Building an
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
d Contents is on an ACV basis.
IF YOU RENT YOUR HOME:
You should buy your own liability and personal property coverage that will cover the contents and personal belongings that you have in your home.
WHO INSURES THE ACTUAL BUILDING (HOUSE, APARTMENT):
The landlord or the owner of the property is the person who is responsible for paying for insuring the actual building in which you are livi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
g.
WHAT IS A RENTER’S POLICY:
This will pay for the replacement of your personal belongings such as furniture, clothing, and other things in your home when disaster strikes such as fire, hurricane, theft, and vandalism. It covers liability (injury or damage to property of others while on your property), and it covers additional living expenses.
WHAT IS “ ADDITIONAL LIVING EXPENSES”:
This i
.
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
what it would cost you if your home is damaged to the extent that you could not live in it and you had to live somewhere else while your home was being repaired or rebuilt. It pays for expenses above what you would normally pay. For example, if your mortgage is $800 per month but it costs $1400 per month to stay somewhere else this coverage would provide the difference of $600. The same is true of y
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
ur food, laundry costs and any other activity that you could normally do at home and now must pay extra for. This does not include things like entertainment.
CHECK YOUR POLICY
Now is the time, before disaster strikes, to get out your policy and review it with your agent. Make sure you are covered for everything you need. The cost to upgrade you coverage is probably less than you might think
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products