E-Articles - Reference and Education

OK. You didn't get accepted at any of the schools you applied to. What should you do now?

Deal. Get over i

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

t. And consider what you're going to do next year. If you decide to re-apply, you need to assess what went

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

Examples of combination products may in

rong and resolve to improve it.

Determine what you need to change. You definitely need to do

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

something different, because your previous approach didn't work. Don't turn in the same essays.

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

Analyze your qualifications versus your target schools' average stats and requirements. If you are appl

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

Combination pro

ying with below average stats at more than two schools and are not from an under-represented minority, you

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

re relying on miracles and not applying effectively. You either need to improve your profile or apply to

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

less-competitive schools.

Seek feedback. Some programs, particularly MBA programs, give construc

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

ive feedback to re-applicants. If your school provides that service, take advantage of it ASAP. You want

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

to hear the criticism as early as possible so that you have as much time as possible to deal with any defec

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

s or weaknesses. Furthermore, some schools only provide feedback during a small window of time. So don't

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

Following aspects would a

delay.

Evaluate your application. Do your essays and letters of recommendation (if you have acce

dd to the challenges in developing combination products:

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

s to them) add to the reader's knowledge of you? What could you do to improve them? Consider using Accepted.c

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

om's application evaluation service

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

to help you with this step.

Work on weaknesses. For example, if you applied to medical school wi

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

th limited or no clinical experience, start volunteering at a local free clinic or hospital. If you appli

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

Professional from academic institutions, pharmaceutical industries, health care indust

d to business school with a low GMAT, study for and retake the test.

Prepare to highlight valuable

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

recent experiences. When you reapply, you want to show that you are "new and improved." For example, i

.

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

you are pre-law and worked for the last six months at the DA's office, you will highlight that experienc

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

Companies that provide selfless information through particip

e, related achievements, and lessons learned in your resume and/or essay when you reapply.

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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