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You're driving on road one night, then you notice there's a police cruiser following close behind you. You figure the cop just wants to pass you, so you move over one lane, except he moves over too and stays on your tail, then you see the flashing red & blue lights then "Woooop!!! wooooop!!!" You must be won

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

dering why you were pulled over. You weren't speeding nor breaking any traffic laws and your tag is not expired. Maybe it's just a burned out taillight. "Sir may I see your driver's license and registration please." Then comes the shocker! "SIR... step out of the vehicle." You get patted down for weapons, dr

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

Examples of combination products may in

ugs, etc.. "You're under arrest for outstanding warrants." On go the handcuffs "Zzzzkkkkkk! Zzzzkkkkkk!" "You have the right to remain silent..." By now, you must be thinking "OH S---!!!". "I've never been arrested in my life!" After you've been booked at the county jail, strip searched, fingerprinted, and m

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

ybe spent the weekend in the slammer, you go before the judge only to find out you're free to go, all charges dropped because it turns out you're not the person they were looking for.

Is this a case of mistaken identity, or more likely, a case of STOLEN IDENTITY, or criminal identity theft. The most common

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

scenario is during a traffic citation or misdemeanor arrest, the imposter fraudulently provides to law enforcement somebody else's identification, usually always that of a friend or relative, then skip town and simply not pay the traffic fine or fail to appear in court as required. Unlike financial identity

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

Combination pro

heft, the victim is usually always known to the imposter. The judge will of course issue a warrant for his arrest. In many cases, the imposter either stole or fraudulently acquired a phony driver's license or ID card in the victim's name. The impostor is most often wanted on outstanding warrants for failure

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

to appear. The victim is usually arrested during a routine traffic stop. This type of identity theft is easiest where the age and appearance of the imposter and victim happen to be very similar. Police are tending to be much more cautious today in order to avoid false arrest lawsuits. Fortunately, unlike fin

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

ncial, criminal identity fraud is rare.

Sometimes, the imposter was arrested for a serious charge such as a felony or drunk driving, and the victim's identity ends up in the criminal database system. The victim might in for a real shock when he is told he cannot buy a gun because he failed the instant backg

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

round check, or is one day called into his boss's office, to be informed he is being fired because a criminal record showed up in a routine employee background check. In the end you probably wished this imposter were caught in Saudi Arabia where he would be sentenced to 100 lashes in the public square.

Unfo

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

tunately, the criminal justice system does not yet have a decent contingency plan in place to clear an innocent person's name. The burdon of clearing one's name lies mostly with the accused, sometimes with steep attorney's fees.

Procedures to clear your name from criminal databases varies according to state

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

, or even individual counties. Some states already have special procedures in place for victims of criminal identity theft. Ask your state Attorney General's office.

If wrongful criminal offenses are linked to your name, first contact the original arresting police/sheriff's department who originally arreste

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

Following aspects would a

d the impostor, or else the court who issued the arrest warrant and file an impersonation report with them, and confirm your identity. Ask the police department to take your fingerprints, photograph you, and make official copies of your photo IDs, I.e.: driver's license, passport, etc.. To claim your innocen

dd to the challenges in developing combination products:

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

e, ask the police to compare your fingerprints and photos with the imposter's.

Maintain a detailed log of all your phone conversions, paperwork, email messages, contacts, etc.. Keep a detailed record of all your expenses incurred. When writing the authorities you should always use certified mail with return

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

receipt. Email is generally not considered secure for sending confidential private information, so it's not recommended if you can avoid it. The rule is never send out something via email that would not want to share with the public. Changing your social security number is rarely recommended as that usually

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

causes more problems than it solves.

If the arrest warrant is from another state or county, ask your local police dept. to forward your impersonation report to the agency of the jurisdiction where the arrest warrant, traffic citation, or criminal conviction originated.

The police/sheriff's dept should reca

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

ll any arrest warrants and issue you a clearance letter or certificate of release in the event you were arrested and booked. It's essential to keep this document with you at all times in case you might be falsely arrested again. Have official copies made at the courthouse, in case it gets lost. Ask the agenc

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

Professional from academic institutions, pharmaceutical industries, health care indust

to file the record of the follow-up investigation establishing your innocence at the D.A's office and/or the court in the jurisdiction where the crime occurred. This will result in an amended complaint. Unfortunately once your name ends up in a criminal database, it's difficult to get it completely removed.

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

Ask that the key name or primary name be changed from yours to the imposter's name, or else to "John Doe" if the imposter's true identity is unknown, with your name noted as an alias.

You will also want to clear your name within the court records. Determine which state law(s) will help you with this and ho

.

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

. If your state has no formal procedure for clearing your record, contact the D.A.'s office in the county where the case was originally prosecuted. Ask the D.A.'s office for the appropriate court records needed to clear your name. Unfortunately in some situations, you may have no choice but to hire an attorn

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

Companies that provide selfless information through particip

ey to help you clear your good name. You may want to ask your state DMV if your driver's license was used by the imposter. Ask them to flag your files for possible fraud.

Overall, your best defense is prevention. Pick your friends carefully, and safeguard your drivers license, passports or other forms of ID

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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