Advice Pool - Health and Fitness

My daughter, Alissa, was eleven years old when she was diagnosed with type 1 diabetes.

At that time we knew li

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

ttle about diabetes, but realised that the staff at her school knew even less!

We drafted the following inform

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

Examples of combination products may in

ation which we adapted and changed at the beginning of each school year, providing a sheet to the school and re

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

questing that it be handed to all her teachers and posted on the staffroom noticeboard.

Here are the key po

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

ints that we included on the sheet:-

Photo - we included a recent photograph of Alissa so that visi

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

Combination pro

ting or supply teachers had a visual cue to help pick her out from the rest of the class.

Brief info about

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

your child – how long ago they were diagnosed, whether they’re on injections or an insulin pump

Symptom

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 of low blood glucose levels – these vary from child to child. Put the main three or four symptoms in a b

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

ullet pointed list.

Sugar and snacks – ensure that the teacher knows that it’s essential that your chil

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

d is permitted to eat snacks or sugar without drawing attention to themselves.

Feeling ill – if your ch

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

ld feels ill, the staff need to know that they should be accompanied to see the staff in the medical room.

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

Following aspects would a

How to help – usual location of sugar/glucose if your child is unable to locate it for themselves. Importa

dd to the challenges in developing combination products:

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

nce of giving a snack when your child is feeling able to eat it.

When to call an ambulance – this helps

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

staff realise that this is not an overreaction to an unconscious child, but the right and appropriate response

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

.

Contact information – for parents, also phone number of diabetic nurses in emergencies.

Your health

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

care professional may be able to provide you with an information sheet like this.

We also talked about our co

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

Professional from academic institutions, pharmaceutical industries, health care indust

ncerns to the local diabetic nurse, who was able to visit the school and help inform them of the health needs a

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

nd requirements of diabetics.

Most of all, we talked to the staff at the school so that they knew us and were

.

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

happy to phone us with any queries.

Thankfully, both the staff and Alissa's friends were all very supportive s

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

Companies that provide selfless information through particip

o that, though her school years were not without incident, she has nothing but happy memories of her time there

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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