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Advice You - Win The Battle Against The Clutter!
We all lose the battle against the clutter because we do not equip ourselves with the requisite tools. What tools, you may ask in puzzlement? The 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
ools that will help you organize yourself and discipline the paper that pours into your office. Oh yeah? What are they? You ask. Well, I had thos
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
questions too, till I discovered the wonderful power of using office accessories for doing my job. It helped me win the war against the paper regime
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
and establish total control over my business.
Here is what I did. I purchased two desk trays to help me clean my desk. The first one I labeled inb
Here is what I did. I purchased two desk trays to help me clean my desk. The first one I labeled inb
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
x and the other outbox. I decided to put everything that came in into the inbox and everything I disposed into the 'outbox'. That took some time to
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
become an established habit, but in the end, I achieved what I set out to do. The paper on my desk became more disciplined and the chaos reduced gra
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
ually until there was none. My friends who mocked my efforts soon followed suit and the office began to take on an appearance of neatness and orderl
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
ness.
The achievement was all the more pleasing, because we began to realize the peril we had been in. The messy desk was burying all our important
The achievement was all the more pleasing, because we began to realize the peril we had been in. The messy desk was burying all our important
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
documents and forcing us to waste precious time in searching for it. We were attending to trivial work while our important work was gradually gettin
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
g delayed. Then we were getting into a panic and messing up on the work in our hurry to get things done. The desk tray was an excellent idea.
The b
The b
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
autifully crafted desk trays that I had picked up from SuccessImage added beauty and grace to
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
he room and enhanced the look and feel of the desk at which I worked. We all loved looking at the beautifully polished hand finished hardwood pieces
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
that matched with the paneling of the office. Functionally the pieces helped us clean up our desks and create space for files that were current, ref
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
erence paper required for information; archive files and papers that had been closed; and so on. We examined every single paper on our desk and took
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
the required action. We threw out irrelevant paper and made an effort file all the loose papers. The desk trays were very useful in organizing this
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
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
process.
When we had done the preliminary task of cleaning up the desk trays helped us keep track of work efficiently and control the volume of flow
When we had done the preliminary task of cleaning up the desk trays helped us keep track of work efficiently and control the volume of flow
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
of paper. In due course we added a third desk tray to our desks and label
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ed it pending. All mail that could not be attended to immediately found its way into this tray and stared at us till we disposed them off. In fact
.
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
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
e began a race to clear our pending trays so that we could pat ourselves on our backs and claim to be efficient.
All of us are now at a stage where
All of us are now at a stage where
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
e think we need to augment our desks with a fourth tray called Reference. We shall be getting it in pretty soon. What a boon the desk tray has been
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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