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Do you want to get a mortgage broker or lender license? Do you need to get it NOW? I am frequently asked how long it will take for a mor

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

tgage company to get a mortgage broker or lender license. Unfortunately, it depends upon which state you are asking about.

There are the

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

Examples of combination products may in

less populous states, which also tend to be the less popular states, such as Iowa, New Hampshire, Arkansas, and Mississippi, where the fir

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

st review takes less than 3 weeks. If the application is perfect, then you have a license in your hand in less than one month. The other e

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

d of the spectrum is New York, which can take 8 to 9 months, and I've never seen a perfect application submitted to New York.

Many times,

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

Combination pro

the problem is that the mortgage company is so eager to get that application in to the Banking Department that they do not submit each doc

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

ument that is requested or answer every question. The licensing reviewers will not let you skip a question or leave out one of the require

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

back-up documents, i.e., letter of reference, current financial statement, or official bank or certified checks instead of company checks

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

for the fees. The devil is always in the details. You cannot be too detail-oriented when submitting a license application.

Another issue

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

that slows down the application process is the time of year in which you submit your license application. If the banking department is al

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

o in renewal season, you will experience a slower-than-usual timeframe. A few states have licenses that never expire so that is not always

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

Following aspects would a

an issue. However, most states issue licenses that need to be renewed every year or every two years. Most licensing departments are under-

dd to the challenges in developing combination products:

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

staffed. When renewal season comes around, a reviewer may be pulled from new applications and re-assigned to processing renewal applicatio

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

s. That means a new application sits in a corner for maybe a month until the backlog of renewals has been cleared. Or the banking departme

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

t will ask you if you want to wait until all new licenses are issued to avoid the need for instant renewal on a license that you’ve held f

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

or maybe a month.

If you consult with a company or law firm that specializes in mortgage company licensing and you get an answer to the q

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

Professional from academic institutions, pharmaceutical industries, health care indust

estion "how long will it take" that sounds much shorter than the responses you have been receiving from other companies or law firms, find

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

out why they can give you such a favorable answer. It's better to know upfront that the process is slow than to gear up and hire loan offi

.

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

cers for a license that won't be in your office for several months, no matter what you have been promised. But sometimes, a law firm has

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

Companies that provide selfless information through particip

good relationship with the application reviewers and the reviewers will make sure that the application is sped through the review process

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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