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Meet your commitments. Do what you promise and don’t promise what y

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

ou can’t deliver. Meeting commitments strengthens relationships and builds t

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

Examples of combination products may in

ust. You need both to solve messy problems. If the situation changes and you

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

have to change a commitment you made in good faith, let everyone know right

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

way so they can make appropriate changes to their own plans. It seems obviou

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

Combination pro

, but many people don’t manage to do this.

Managing your commitments succes

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

fully means you must be organized yourself, which brings us back to project

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

management—with you being the overall project. That means you’ll need to wri

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

e down all your specific projects, identify tasks, set priorities and keep t

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

ack of progress and due dates. Each time you consider a new assignment, star

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

by estimating the resources needed (mainly your time) and make sure you’ve

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

Following aspects would a

ot what you need. Don’t accept the assignment if you don’t have the resource

dd to the challenges in developing combination products:

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

necessary. If the new assignment is more important than some of your curren

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

projects, then get the priorities and expectations adjusted by making expli

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

cit agreements with the stakeholders in the projects getting pushed back.

L

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

ke any project, of course, you’ll need to keep updating your project plan so

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

Professional from academic institutions, pharmaceutical industries, health care indust

that it reflects accurately everything you’re working on. You’ll be able to

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

ell more easily if you can accept a new commitment, and if anything starts s

.

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

ipping, you’re in a position both to recognize that it’s happening and also

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

Companies that provide selfless information through particip

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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