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When you are waiting for your offer to be accepted, countered or rejected,

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

time seems to move in slow motion. If you didn't specify a time limit in yo

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

Examples of combination products may in

ur offer, you may be waiting a while. Even if you did, the seller has the o

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

pportunity to amend the time frame by countering your offer.

Sellers will

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

often do this to keep you on the hook so to say and buy a little more time.

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

Combination pro

They know you won't accept the counter-offer, but they are hoping that 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

will counter back.

Most buyers want the seller to respond quickly. After

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

ll, it means that their search for a home is almost over. Buyers are eager

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

to hear an acceptance to their offer as soon as possible.

In a buyer's mar

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

ket, many buyers are less urgent. They often give a seller a longer time fr

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

ame, but in doing so, they run the risk of the seller letting other potenti

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

Following aspects would a

al buyers know about the offer.

If you failed to not the time frame for ac

dd to the challenges in developing combination products:

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

ceptance on your offer, you need to correct this as soon as possible. Email

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

or fax the seller or seller's agent about the time frame under which the o

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

fer will remain open. If it has been a few days since you presented the off

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

er to the seller, you can definately ask for an answer in twenty-four hours

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

Professional from academic institutions, pharmaceutical industries, health care indust

. That is more than acceptable.

If you do notify the seller of a time fram

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

e after presenting the offer, make sure that you back up your request with

.

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 desire to purchase the home. This will reinforce your interest in the

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

Companies that provide selfless information through particip

property and could help the seller make a decision in your favor. Good Luck

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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