References - Home and Family

With days filled with diaper changes, feedings, playdates, potty training, homework and mountains o

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

f laundry, being a Happy Mom is something Moms rarely have time to contemplate. We surveyed a group

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

Examples of combination products may in

of 50 moms and asked them if they considered themselves happy. But, we didn’t let them answer right

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

away. We gave them ten solid minutes to really think about it. And then, when each and every mom re

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

ponded “Yes, I am a happy mom!” we asked the tough question – why? We compiled their responses into

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

Combination pro

a ten-question questionnaire to find out if you truly are a Happy Mom…

1. Are you secretl

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

glad to see your children get on the bus to go to school so that you can have time to yourself? Bu

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

, then are you watching for them out the window and missing them by the afternoon?

2. When walkin

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

past your child’s room at night, do you sometimes pause and are unable to resist the urge to peak

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

in and watch her sleep?

3. When your child does something nice and unselfish for someone else wit

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

out being asked, do you silently congratulate yourself on bringing a compassionate, caring person t

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

Following aspects would a

the world?

4. Can the words, “I love you, Mommy” make you forget bills, squabbles, the lack of fo

dd to the challenges in developing combination products:

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

d in the house and the mounting piles of dirty laundry and fill you with a sense of bliss?

5. Do y

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

ou yearn for a night out with your girlfriends and then when you finally get it, do you talk incess

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

ntly about your children?

6. If you travel alone and stay in a hotel, do you find the silence deaf

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

ning and keep waking up wondering why you are not being asked for a nighttime glass of water or hel

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing a sleepy little person use the bathroom?

7. Are you known now to more people as “So-and-so’s M

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

ommy” than by your own first name? Do you now introduce yourself as "Somebody's Mommy" and not your

.

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

own name?

8. Have you ever been honked at at a red light because you started daydreaming about you

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

Companies that provide selfless information through particip

child’s face?

If you answered Yes to 1 or more of these questions, you are a Happy Mom so rejoice

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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