select?
Which Combinations can address unmet needs of the patients?
Do combinations increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product development?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of developing new procedures for reviewing their safety, efficacy and quality.

Professional

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

Examples of combination products may include drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

There is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixed dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination products have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been increasingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combination products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically 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 products. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are finding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would add to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination products are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combinations increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product development?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of developing new procedures for reviewing their safety, efficacy and quality.

Professional

ous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixed dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination products have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been increasingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combination products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically 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 products. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are finding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would add to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination products are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combinations increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product development?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of developing new procedures for reviewing their safety, efficacy and quality.

Professional

e cycle management. Even the companies having product patents are trying to extend their product life cycle through the combination products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically 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 products. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are finding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would add to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination products are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combinations increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product development?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of developing new procedures for reviewing their safety, efficacy and quality.

Professional

by physicians while others suffered. Companies involved in development of combination products are finding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would add to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination products are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combinations increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product development?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of developing new procedures for reviewing their safety, efficacy and quality.

Professional

select?
Which Combinations can address unmet needs of the patients?
Do combinations increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product development?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of developing new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care industry and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the development. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through participation in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products.