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Over the past few years pre-employment background checks have gained significance for employers big and small. Companies can either execute the r

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

equired activities in-house or can outsource them to human resource companies that specialize in carrying out background checks.

There is a lot

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

Examples of combination products may in

of paper-work, co-coordination, and follow-up that goes into conducting a background check and for this reasons companies prefer to get the job d

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

one by an outside agency. The background checks have to be done in accordance with the Fair Credit Reporting Act (FCRA). According to the FCRA, a

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

individual who earns less than $ 75,000 per annum cannot be reported for criminal acts that are more than seven years old. Also, the checks can

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

Combination pro

only be done with the signed consent of a job seeker.

Companies that wish to execute background checks should do so as a matter of policy and sh

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

ould make this known to job seekers. This acts as a deterrent for applicants who intend to hide information. if an external agency is hired to do

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

the check then one should check if the agency is conversant with FCRA requirements, relevant state and federal laws, and the equal employment opp

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

ortunity laws. The sources from which the company obtains its information should be verifiable. Normally, the information is acquired from consum

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

er reporting agencies that report on education, credit history, and criminal records.

A standard employee background check verifies driving and

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

redit records, employment background, Social Security Number, education, and military background. The check can also include drug tests and check

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

Following aspects would a

ing on references provided. The nature of the background check varies with job requirements, for example drivers are normally subjected to a stri

dd to the challenges in developing combination products:

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

cter reference check and their motor-vehicle records are looked at more closely. Similarly, the credit records of accountants and those who may b

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

e required to manage a company’s finances are scrutinized more than the records of others.

When availing the services of an outside agency, fact

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

rs such as the extent of the check, nature of information desired, contact points at both ends, and person assuring the accuracy of information p

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

rovided should be decided beforehand. The contract between an employer and a third party Human Resource company should address privacy and discri

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

Professional from academic institutions, pharmaceutical industries, health care indust

mination laws, timeframe for submitting information, indemnities, insurance against errors and omissions, and evidence of professional liability.

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

Employers should compare the data obtained from various sources during the process of a background check. Information in a job applicant’s resum

.

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 should be checked with facts stated in the job application. There should be no inconsistencies in the information provided in the cover letter

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

Companies that provide selfless information through particip

and facts offered during the interview. Common things that are cross-checked include the Social Security number, education, and the date of birth

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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