Actual - Computers and Technology

The U.S. Department of Transportation continues its war against laptop battery terror in the skies, w

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

arning passengers to take precautions while flying with a laptop or cell phone. Any suspicious lithiu

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

Examples of combination products may in

-ion battery behavior should be reported.

A safety advisory released Thursday was prompted by recent

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

on-board fires ignited by li-ion battery devices.

The department advises travelers to keep spare ba

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

teries in their original retail packaging or covered with insulating tape to protect them from contac

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

Combination pro

t with metal objects. Each battery should be sealed in its own protective case and placed in carry-on

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

baggage rather than checked-in. Batteries can be better monitored and dealt with by a flight crew in

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 overhead compartment than the cargo area the report said. The department also recommends batterie

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

be bought by a reputable source.

In May, a spare li-ion battery stowed away in a passenger's comput

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

er case, neither covered with insulating tape nor placed in a separate protective case caught fire. A

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

flight attendant was able to remove the burning case from the passenger cabin and toss it onto the ra

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

Following aspects would a

p.

More recently, on Feb. 10, a plane departing from JFK International Airport was a victim of alleg

dd to the challenges in developing combination products:

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

ed battery fire in an overhead compartment. Thanks to fast action by the crew, no injuries were repor

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

ed and the craft returned to JFK for an emergency landing. The incident is still under investigation,

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

but initial reports indicate batteries were in fact involved.

According to the report, as a federal

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

regulatory agency the department recognizes that any fire aboard a passenger flight is unacceptable.

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

Professional from academic institutions, pharmaceutical industries, health care indust

The Air Line Pilots Association, in conjunction with the International Federation of Air Line Pilots

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

Association plan to publish a safety alert and safety bulletin concerning the hazards of li-ion batte

.

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

ries and procedures that crew members should follow in the event of a battery fire. Both organization

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

Companies that provide selfless information through particip

hope to fight back against battery attacks by revising safety standards and through public education

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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