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Late last month, The Washington Post ran a half-page story about Daniel Bleje

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

r, a 52-year-old who died of Creutzfeldt-Jakob disease (a human version of ma

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

Examples of combination products may in

d cow disease). The article pulled at the heartstrings, and captured his pers

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

nality so well that you wanted to share a beer with him.

He may have contrac

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

ted the disease due to contaminated surgical devices used when he underwent a

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

Combination pro

series of brain operations in the late 1970s. The article goes on to say that

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

dozens of patients over the past five years have potentially been exposed to

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

the very deadly brain disorder due to the infectious agent which remained on

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

the reused medical instruments despite sterilization.

After reading about th

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

e tragedy his family and others have had to endure, the article ran a quote f

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

om a neurologist at Seattle’s Harborview Medical Center. After pointing out t

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

Following aspects would a

hat reusable biopsy forceps cost $800 each, the doctor said, “That’s a lot of

dd to the challenges in developing combination products:

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

money. There’s a cost-benefit ratio.”

Assuming he’s right, it still sounds

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

ike a cold dismissal of a person’s life to a large portion of the public. And

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

it was an unnecessary comment, since the hospital changed its policies and w

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

ll no longer use disposable instruments more than once in cases where uncerta

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

Professional from academic institutions, pharmaceutical industries, health care indust

inty exists.

Here’s what he could have said instead: “After looking at the e

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

vidence, we decided to take an additional precaution and change our hospital’

.

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

policies to provide our patients with an even safer facility.” It may not be

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

Companies that provide selfless information through particip

Hemmingway, but it’s a lot better than offending a large swath of the public

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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