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Advice Pool - 3-11 Time Change or 911 Style Cyber Attack?
As he took a sip from his paper bag, obviously alcohol from his breath he admitted to be
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
ing part of a secret government covert group working inside the United States. He said
; 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
on March 11, 2007 there would be an attack much like 9/11. He said it would occur on th
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
e day of the 3-11 on the day of the time change and it would be a 9/11 style cyber attac
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
k.
He said the reason for the time change is that people would be very tired due to the
He said the reason for the time change is that people would be very tired due to the
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
change and therefore be unable to reason the events as they unfolded very rapidly. He
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
said this was all part of the conspiracy. At first I completely laughed it off but he l
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
oked at me with steely eyes and said; "No joke my friend." He then stated; on
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
311 the United States will be attacked and its computer infrastructure will be brought
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
to its knees. This time I did not laugh. :(
He stated that the attack would be done wi
He stated that the attack would be done wi
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
th the help of Chinese hackers and the United States black ops group and would be blamed
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
on Al Qaeda, which would simultaneously take down three major facilities, of which he t
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
old me he could not say or he would have to kill me. Being a strong young man I was not
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
worried about death so I pressed him for more answers.
He went on to give me minor det
He went on to give me minor det
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
ils and then he said;
"I've already said too much"
and he left in a
"I've already said too much"
and he left in a
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
haste. I have heard a lot of conspiracy theories in my day but this drunken gentleman
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
standing out front of the Starbucks while I sipped my latte somehow seemed credible.
Yo
Yo
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
u decide is this fact or fiction? I certainly hope this article is of interest and that
.
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
is has propelled thought. The goal is simple; to help you in your quest to be the best i
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
n 2007. I thank you for reading my many articles on diverse subjects, which interest you
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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