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Top Articles - Wells Fargo Contacts Customers About Recent Data Theft
Wells Fargo is contacting an undisclosed number of home-mortgage customers about the d
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
elay in notification regarding a potential security breach.
Wells Fargo is reporting
Wells Fargo is reporting
; 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
hat it agreed, at the request of law enforcement officials, to not notify customers ab
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ut the suspected theft of a computer loaded with customer information. That informatio
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
included names, addresses and Social Security numbers.
The lender says that there is
The lender says that there is
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
no indication that the information has been used. The company says that the computer c
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
ntained no depository or account numbers.
Company officials have also said that there
Company officials have also said that there
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
are "two layers of security" that prevent unauthorized access to computer information.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
The company confirmed that the computer was reported missing earlier this year.
Well
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
Fargo is not releasing many details about the incident, including how many customers
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
re affected. Letters will be mailed to customers this month.
"We contacted law enforc
"We contacted law enforc
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
ement when we learned of the situation, and an investigation began. They directed us 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
delay notifying all customers because they were concerned it would jeopardize the inv
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
stigation," the letter explains.
The company states that law enforcement "no longer b
The company states that law enforcement "no longer b
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
lieves notification would interfere with the investigation, and we are contacting you
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
ow to alert you of the situation and suggest ways to reduce any potential risk to you.
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
Wells Fargo spokesman Tom Unger said the missing computer affected a "small percenta
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e of customers" from the United States. It was reportedly lost in transit while being
.
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
ransferred between offices. No further information is being released.
"All I can tell
"All I can tell
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
you is there's no indication the information has been misused or accessed," said Unger
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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