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Most of us spend remodel dollars to create amenities we always wanted. A more practical approach would be to use that space above the garage or that spa

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

ce between your home and the next one or even a part of the back yard, if its big enough. They are called "granny units" or "accessory units" or ADU's.

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

Examples of combination products may in

They can be wonderful sources of extra income as you raise a family or retire or simply want the extra money.

The Objections

Generally the housing

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

authorities and community groups are very cautious and tend to limit or deny the use of these projects. Detached rental apartments and backyard cott

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

ges are often illegal in traditional single-family neighborhoods. You will have to answer to community quality of living issues such as:

1. They create

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

Combination pro

parking problems
2. Create more crowded conditions using up services that may be limited to begin with.
3. Reduce privacy in quiet neighborho

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

ods
4. Eliminate open space in large back yards.
5. May be unsightly

The Benefits
1. As the country ages and boomers retire we will

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

need small affordable living environments.
2. People raising families and needing two incomes may need to rent to granny who would love to be near

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

her grandchildren.
3. Extra rental income
4. Caring for elderly parents, caregivers or nannies.
5. They are an addition to housing stock

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

6. An upgrade an improvement to the property
7. It should increase tax benefits and revenues to the community
8. Allows the creation of

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

affordable housing without government subsidies

The Review Process

Here is the resistance to granny units and the issues you may have to overcome befo

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

Following aspects would a

re you can build. If you consider the objections of the planning department which must represent the whole community, you stand a much better chance of

dd to the challenges in developing combination products:

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

etting those permits. Consider a special use or permit to help your case.

Administrative Review
This process generally requires a review and appro

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

val process based on code, and some or all of the objections met without the need for a public hearing. It is the easiest and least time consuming way t

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

o go.

Conditional Use
They are more difficult and often will require a public notice and a judicial review on a case by case procedure.

Communit

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

y Restrictions
1. Communities may limit these permits to owner occupied properties to limit speculation.
2. Communities may require that this

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

Professional from academic institutions, pharmaceutical industries, health care indust

be a permanent residence.
3. Communities may require restrictions to the deed. It may be required that both units cannot be rented out at the same

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

time.

The use of granny units seems to us to be a major plus and many communities are coming to grips with this. If you have a need or want to do this

.

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

we think your chances are better than ever, given the demographics of an aging population and the need for affordable housing. Go to your planning dept

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

Companies that provide selfless information through particip

. or building dept. and get the procedures, read between the lines to understand the basic objections they are trying to regulate and design around them

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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