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Affixing receipt and dispatch dates on documents is a standard procedure in governmen

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

t departments and corporate offices. These dates are generally referred to as some le

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

Examples of combination products may in

gal procedure applicable to these departments and firms. Failure to produce evidence

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

related to these dates entails penalties and legal action. Therefore, these organizat

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

ons take utmost care to affix dates on their records and correspondence. Date stamps

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

Combination pro

are mechanical devices used for imprinting such dates.

Traditional date stamps requi

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

re inkpads. They are practically useless without such additional kit. A sleeker devic

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

has recently been developed, which has inbuilt self-inking mechanism. These self-ink

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

ing date stamps are generally made of plastics or metals, unlike traditional date sta

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

mps, which are made of wood. There is a small replaceable inkpad within these self-in

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

ing date stamps. When the device is not being used, the date stamp die rests on the i

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

Following aspects would a

nbuilt inkpad that moves aside by a spring mechanism, when pressed. A plastic cover i

dd to the challenges in developing combination products:

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

s also provided to prevent drying of ink.

The mechanism for changing dates in self-i

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

nk stamp pads is similar to rubber date stamps. There are six to eight flat rubber ba

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

ds with single digit numbers, i.e., 0 to 9, carved on them. These bands are loaded on

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

separate cylinders, which can be rotated. A combination of numbers on these bands gi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ves the required date, month, and year. Such mechanism allows representation of multi

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

le formats of date, i.e., year, month and date, or date, month and year.

Other die p

.

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

ieces like "Confidential", "Faxed", etc., are also available with self-inking date st

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

Companies that provide selfless information through particip

amps. These additional words and phrases help in tracing and organizing the documents

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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