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My wife and I do too much for our children and the guilt has become so overwhelming, I feel compelled to confess publicly in the hope that someone can guide us out of the dark, twisted labyrinth we disappeared in more than four years ago. T

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

he shame of committing countless clandestine acts, relying upon deceit, trickery, and cajolery for the sake of our children has become too much to bear and can no longer be justified by the need to get a decent night’s sleep.

I refer of co

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

Examples of combination products may in

rse, to the school project.

If ever there was a need for parents to unite against a common enemy it is the school project. I’ve nothing against reports but if a homework assignment requires plaster of Paris, glue, cardboard, cement, newspa

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

ers cut into strips, paint, clay, wood, beads or the use of arc welding equipment – let’s return to an agrarian society where wheat was once ground into flour for food and not to serve as an adhesive ingredient in Paper Mache.

For those of

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

you unfamiliar with take home school projects, or for those of you fortunate enough to have suppressed such memories, there are seven stages to every school project. Let me enlighten you:

Stage 1. The Introduction and the Delivery

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

Combination pro

f False Hopes. In this stage, a child announces at dinner that they have been requested to make a diorama, say one on the book, “The Jewel Princesses and the Missing Crown”. A parent, generally the mother, will announce gaily that

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

she has been saving shoe boxes for such an occasion, in much the same way expectant mothers knit booties. There will be a brief discussion on how the diorama will be constructed, including the type of materials needed to ensure that it is a

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 beholding to the eye as it is informative. A sense of confidence that all is in hand will fill the room. A parent will casually ask between bites when the project is due, the child will respond that it is due in one month and the parents

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

ill process that information to mean that they never have to be concerned about this again.

Stage 2. High Noon. The night before the day before the project is due, the child will approach one or both parents and shriek, “

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

hat about my diorama?” One or both parents will respond, “Why did you wait until now?” There will be finger pointing, recriminations and the gnashing of teeth during this stage.

Stage 3. It Takes a Village to Decorate a Shoe Box
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
rong> On the day before the project is due, work will be parceled out to all family and extended family members within a radius of fifteen miles. It will take no less than three trips to the local crafts store, the Home Depot of the elemen
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
ary school set, to assemble all the accessories necessary to complete the diorama. A grandparent will be dispatched to locate a roll of contact paper once spotted in their basement six years prior.

Stage 4. We Are All Being Graded<
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
strong> The child will begin to assemble the diorama but it will not pass the standards set by the parent or parents who worry that the little 8” x 12” box could potentially be seen by someone they know over the age of eight. The Internet
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
s dispatched and graphic items are printed in an enormous volume to provide the greatest number of decorating options. A sibling of the student will be reduced to tears when a beloved toy doll is surgically altered to fit inside the box. Ne
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
gative emotions run high throughout the duration of this stage, despite claims that the maimed toy will be replaced, that future projects of such scope and magnitude will commence at the instant in which they are revealed to the parents, an
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
that the bed is pretty much in scale with the armoire made from wooden matches.

Stage 5. Emerging From the Trial By Fire Generally sometime after 11:00 pm, anger is replaced with a sense of accomplishment when the school
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
project is completed. All the stress and turmoil evident on the faces of the parent or parents will vanish once it is apparent that the nightmare is over. A moment later, the stress returns when the child mutters that this is not how she wo
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ld have done the project if she did it all herself.

Stage 6. The Return of the Prodigal Project Days later the child returns with the project and the grade. Everyone celebrates the “A” they received. The project is placed
.

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
in a position of prominence for a period generally lasting no longer than 72 hours before it is tossed into the trash with the coffee grinds while the child is at school. It is never missed nor spoken of again.

Stage 7. A Clean Sla
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
e A child comes home with a new school project. Repeat steps 1-6.

I’m willing to march in front of the school board if you’re with me on this school project issue. We can get everything we need to make signs at the Crafty Kitchen

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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