Answers - Real Estate

Kate and John had one week to pack up the contents of their home of ten years and relocate it to a new house across town. They woke up every morning anxious and exhausted, m

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

ade little packing progress and went to bed each night feeling the same way. The following Saturday, the moving truck came but Kate and John weren’t ready for them. They spe

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

Examples of combination products may in

nt several hundred dollars that day getting the movers to assemble and pack the boxes that they should have had ready to go a week before. Kate got in the car and began to c

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

ry. Not only was she leaving the place she called home for ten years, but the stress of the previous week was taking its toll on her nerves. What could Kate and John have do

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

ne differently? Is there anything that can make moving day less traumatic? With every move, there is a laundry list of projects that be completed by a certain date. But, you

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

Combination pro

know your home, possessions and you have a deadline. Sounds like a situation just waiting for a plan of action. And that plan will help to get you, your family, and your be

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

longings into your new home, intact, without stress. Here are 4 of AHA’s Top Tips for Stress Free Moving

1) Schedule your move well in advance

The average

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

American life includes 11 moves. Many of these moves occur during the summer months. You’ll find that rental services and other move amenities are more widely available Sep

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

tember through May. But if you must move in the summer, try to schedule your move for mid-month, when moving companies and rental agencies are generally less busy.

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

2) Work out a schedule and collect the necessary materials

If you are doing the packing yourself, work out a general schedule for when certain rooms should be pack

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

ed. Begin hoarding boxes! The photocopy center in your (or a friend's) office building is a good place to begin looking. You can also call grocery and department stores. Fin

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

Following aspects would a

d out from a supervisor when they do inventory, which will yield a variety of different size boxes.

3) Research now to save time later

A good source for i

dd to the challenges in developing combination products:

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

nformation and packing tips is, of course, the Internet. Most moving companies provide packing tips on their Web sites. Some sites provide specific details about how to pack

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

specific objects-from artwork to lawn mowers.

4) Research your moving company well in advance

Information on organizing the move is also available. Refer

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

to the moving planner available on the American Moving and Storage Association's (AMSA) website (www.moving.org). This planner lists activities that should be performed eac

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

h week as your move approaches. This site also contains information on movers that are AMSA-certified. These movers have agreed to a Code of Conduct that requires "complete

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

Professional from academic institutions, pharmaceutical industries, health care indust

disclosure of moving information to consumers, written estimates of charges, timely service and prompt response to claims and complaints."

It is easy to become overwhelmed

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

and stressed at the thought of uprooting your life from one house to another, but moving is simply a series of tasks that need to be accomplished by a certain date. The easi

.

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

est way to eliminate moving stress is to establish a plan that allows for all the tasks to be complete by the specific date, and stick to it.

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

Companies that provide selfless information through particip

from American Homeowners Association (AHA)®

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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