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Step 7 Humbly asked him to remove our shortcomings. as used by Alcoholics anonymous

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

(AA) Narcotics anonymous (NA) Al-anon Cocaine anonymous (CA) Gamblers anonymous (GA)

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

Examples of combination products may in

Emotions anonymous (EA) Sex and Love addicts (SALA) anonymous Co dependents anonymou

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

(CODA) Overeaters anonymous (OA) recovery programs.

Step seven Humbly asked him to

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

remove our shortcomings.

When I was writing my defects, I would burst out laughing

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

Combination pro

t time, when I would see these defects that were causing me and the people around me

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

so much pain!. These defects were so obvious they stood out like a light in the dar

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

. I had brought on so much of my pain by my reactions and in other ways by my lack

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

f action.

So humility was not a case of being ridiculed, but a sense of humility, “

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

es, I am the problem”. So all I had to do was do what my creator wanted, and that w

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

s to use what I had learnt from the first 6 steps to practice opposites, simple, pra

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

Following aspects would a

ctice opposites. In doing so, you are getting your shortcomings removed.

Today I k

dd to the challenges in developing combination products:

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

ow how my creator designed me. I have started to use the, “User handbook”, “The mak

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

rs instructions pamphlet”. It designed me to love other people as well as myself, t

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

care about other people, “To do unto others as you would have done unto yourself”.

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

To be polite, gentle, caring, loving, tolerant, patient, humble, honest, courageous,

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

Professional from academic institutions, pharmaceutical industries, health care indust

gratitude and to try your best to live a blameless life. In doing so I will have pe

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

ce of mind, knowing I am trying my best and that is all that I can do, my best. If

.

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

don’t follow how my creator designed me, then I will suffer and those around me wil

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

Companies that provide selfless information through particip

suffer. So all I had to do was practice opposites !

see http://www.the12steps.co

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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