Advice Pool - Relationships

Congratulations on your engagement! Now it’s time to start planning your dream wedding. This can be a very daunting task, bu

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

t not to worry, there are tons of resources available to help you plan everything from the initial preparations to the weddi

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

Examples of combination products may in

g itself and even life after the wedding.

The importance of staying organized cannot be overlooked. Planning worksheets, on

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

line resources, and a good old fashioned notebook or binder go a long way in keeping the integral details of your wedding ne

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

t and in order to avoid any unnecessary panic or worry as your big day approaches.

It is best to determine the wedding budg

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

Combination pro

et right from the beginning. There are many costs to consider when planning a wedding, so it is wise to sit down and discuss

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

the financial impact of the celebration before making any definite plans. Deciding how much the bride and groom have to spen

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

d and how much assistance, if any, the couple will receive from family will immediately play a key role in determining the w

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

dding budget.

Many wise couples do not wish to go into debt for their wedding. Financial experts advise against unlimited s

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

pending, knowing it is better to start a marriage without needless liabilities. It is easy to fall into either one of two tr

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

ps: expecting more monetary wedding gifts than actually received and under-budgeting for wedding and honeymoon expenses. Kee

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

Following aspects would a

p in mind that this is your one special day, but a beautiful, personalized and meaningful wedding can be planned on any budg

dd to the challenges in developing combination products:

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

t. Be sure to be realistic about expenses, realizing that a lower price may mean a lower quality of service, but savvy negot

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

iations can yield opportunities once thought to be out of reach. Careful itemization of each expense will make the wedding b

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

dget a success, and securing estimated prices with a contract for each service will help keep you within your budget.

When

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

budgeting, it is essential to determine who will be paying for what. The traditional guideline of financial responsibilities

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

Professional from academic institutions, pharmaceutical industries, health care indust

can be used as a starting point, but keep in mind that many couples are financially independent and may wish to pay for the

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

entire event out of their own pockets. And the guideline is just that; a starting place for your perusal. However you end up

.

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

breaking down the budget and financial responsibilities must work with your own situation and need not follow any ‘rules’. R

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

Companies that provide selfless information through particip

emember that no matter what financial assistance is offered, the wedding is ultimately the couple’s financial responsibility

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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