Main Subject - Business

When Tom Fujiwara, Assistant Public Works Director for the City of Redlands, Californi

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

a, needs to study plans for street repairs or review a map of his city’s storm drain s

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

Examples of combination products may in

stem, he locates and retrieves large documents more quickly and efficiently than ever

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

efore by using the department’s new vertical file storage system.

“We chose vertical

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

ile storage systems because they work. It’s that simple. The cabinets don’t damage our

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

Combination pro

documents and they are very, very easy to access,” he explained. Before adopting vert

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

cal file storage systems, the city’s thousands upon thousands of pages of large drawin

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

s, maps and exhibits required by the department were stored mainly in flat files, or r

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

lled up in tubes in a corner. “It was very challenging to get your hands on the right

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

ocument,” Fujiwara said.

“We now have ten vertical file cabinets to store large docum

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

nts, which are mostly engineering drawings, exhibits and maps, some of which measure f

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

Following aspects would a

om 18” x 26” and 24” x 36” and larger”, said Mr. Fujiwara. The system not only saves

dd to the challenges in developing combination products:

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

pace, it saves time in retrieving and storing documents.

According to Fujiwara, “The

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

ain benefits of vertical files are that you can access and retrieve files as you need

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

hem. It doesn’t destroy or bend the document. What you don’t want, you can slide bac

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

and access only the files you need at that moment. Everything is accessible, easy to

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

Professional from academic institutions, pharmaceutical industries, health care indust

retrieve, and protected” For municipalities like the City of Redlands, flat file cabi

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

ets just don’t make economic sense anymore. Vertical file storage systems can store as

.

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

many documents as 15 drawers of flat files, while requiring 75 percent less space. Ve

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

Companies that provide selfless information through particip

tical file storage systems save time and money, while conserving valuable office space

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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