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On Aug. 29, 2005, hurricane Katrina destroyed thousands of homes on the Gulf Coast. When homeowners were finally allowe

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

d to return to their homes and saw the damage, they began the process of working with their insurers to file their clai

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

Examples of combination products may in

and start over. What they were faced with were claim denials for their homeowner policies.

Zach Scruggs, one of many

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

ttorneys involved in litigation against these insurers, said Forensic turned over the e-mails as part of the pretrial d

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

scovery litigation. Homeowners who where suing State Farm Insurance for Hurricane Katrina claim coverage had accused th

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

Combination pro

insurer of pressuring their engineers to modify reports regarding the hurricane damaged property so that policyholders

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

claims could be denied.

Recently obtained internal e-mails from an engineering firm that helped State Farm adjust cla

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

ims are helping lawyers litigate their claims because of the evidence they have obtained with E-Discovery and Computer

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

orensics. Some of these e-mails are conversations between the Forensic president and CEO Robert Kochan and Randy Down,

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

he firm's vice president of engineering services. In one particular e-mail, it says the firm will continue working with

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

State Farm, but discusses needing to "redo the wording" of a report after a complaint by Alexis King, a State Farm Mana

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

Following aspects would a

er in Mississippi, so "such that the conclusions are better supported."

Alexis King didn't want local engineers to ins

dd to the challenges in developing combination products:

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

ect properties because they were "too emotionally involved" and were "working very hard to find justifications to call

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

t wind damage when the facts only show water induced damage," according to an e-mail. Randy Down questioned the State F

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

arm's motivations and questioned the ethics of the insurer via e-mail with the insurer telling the firm what to put in

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

he reports.

All of this information would have gone unnoticed if it wasn't for the field of Computer Forensics. Comput

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

Professional from academic institutions, pharmaceutical industries, health care indust

r forensics has quickly become a vital tool and source of information for criminal investigators, corporate counsel, an

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

prosecutors. Computer forensics investigators use their skills to identify and restore formatted, corrupted, deleted o

.

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

hidden files from computers or other electronic media while maintaining crucial data trails, time & date stamps and ac

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

Companies that provide selfless information through particip

urate chain of custody & controls. They also obtain access to protected or encrypted data by using specialized software

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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