Advice Pool - Reference and Education

How quickly do you need your contractors license? Can you wait 4, 5, or even 6 months? How ab

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

out waiting almost 7 months to get your license number? I’ve seen it happen too many times.

W

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

Examples of combination products may in

th the current back log at the CSLB, you can expect to wait up to 5 months to get your contract

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

rs license number…and that’s if your application is accepted without being rejected for correct

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

ions.

Here’s the time-line…you submit your application today, it gets reviewed by the Applicat

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

Combination pro

on Technician in 4 weeks, assuming the application is acceptable, it is “Posted” and “Referred”

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 testing, the computer will assign the next available test date at a testing center closest

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

to you. Test dates are currently being scheduled 4 months out, which gives you plenty of time

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

to study your exam materials.

The test day finally arrives and…Congratulations! You’ve passed

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

your test…but wait…how and when will you get your license number?

Now you need to provide a Bo

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

d and Workers Comp and, if you haven’t already, pay the Initial License Fee (ILF) of $150. T

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

Following aspects would a

hese requirements could add an additional 2-4 weeks or more depending on State Fund (if you nee

dd to the challenges in developing combination products:

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

workers comp) and finances (maybe you don’t have the ILF at that time) or can’t get a bond b

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

cause you have poor credit!

So you see, the process can be very lengthy and stressful. But no

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

w you’re asking yourself, “how can I get licensed in less than a month?” Well…I’m going to tell

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

you… The key is…The RME!

If you know of, or can find someone who has taken and passed the exam

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

Professional from academic institutions, pharmaceutical industries, health care indust

s) within the last 5 years…you can get a license in less than a month. Possibly in as little t

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

ime as 2 weeks…and if you have a clean record and can afford an expedite service…even less than

.

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

10 days is possible!

There is, of course, a short cut to every thing. All you need is the r

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

Companies that provide selfless information through particip

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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