Advice You - Business

Hezbollah terrorists are not just destroying homes and towns in Israel. Their actions are also ha

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

ving an effect on the global freight industry. As fighting continues in Lebanon the damage caused

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

Examples of combination products may in

to Beirut airport has prevented any commercial flights to or from the country.

A number of leadi

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

ng freight services (including companies from the UK) have suspended the transport of cargo to an

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

from Beirut airport. Many freight forwarding companies are still transporting goods to Damascus.

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

Combination pro

However if Syria enters the fray in support of Hezbollah with whom it has close links, commercial

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

transportation to that country might also be affected.

One of the key reasons for the cessation

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

of flights to Beirut is the fact that the city’s runway has been damaged. However, if the violenc

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

escalates the issue of safety may also prevent the transport of freight to and from the country.

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

Indeed, only last week two truck drivers were killed at the Beirut Container Terminal where the

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

were waiting to collect cargo to transport out of the country.

Although air freight to Lebanon

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

Following aspects would a

s affected, since the port is still open, transportation to the country has not stopped entirely.

dd to the challenges in developing combination products:

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

This is good news for humanitarian relief organisations keen to send aid supplies to the country

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

Much of the freight needing to be transported to Beirut is being shipped to Damietta, which is

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

he closest safe port. It is then stored in warehouses there until it is ready to be dispatched to

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

Beirut.

This means that at the moment the freight services industry is managing to find ways ar

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

Professional from academic institutions, pharmaceutical industries, health care indust

und the problems caused by Hezbollah’s attacks on Israel and the country’s counter offensive.

Th

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

s is good news for both humanitarian organisations delivering aid to Lebanon as well as to the fr

.

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

eight services industry. However, if Syria joins Hezbollah’s attack on Israel then the implicatio

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

Companies that provide selfless information through particip

s for freight transport to both Lebanon and the Middle East in general could be severely affected

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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