Actual - Legal

Law School Musings (Part 1)

Introduction

As a prospective law student, it is important that you begin to think about what law

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

school is and what you hope to gain from law school. Understanding these principles can help you decide whether to attend law school, which law school to attend, what

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

Examples of combination products may in

“success” in law school should mean to you and how you can use law school to your career and life advantage.

Very early in my law school career – perhaps sometime

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

during the first semester of my first year – I began to formulate a theory that law school is entirely unnecessary to develop the legal skills needed to become an excell

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

nt attorney. Years later, after completing law school and practicing as an attorney in a variety of settings over the course of almost a decade, I am only more firmly

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

Combination pro

convinced that the legal education you will acquire in law school will do little to prepare you to practice law.

Indeed, it was not so very long ago that many att

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

rneys earned their legal education by acting as an apprentice for a practicing attorney in lieu of attending a law school. Many famous attorneys started their careers i

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

n this manner. In fact, some states – most notably California – still provide a mechanism whereby an attorney who has skipped law school may still practice law. If, af

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

er reading the balance of this section, you feel that law school does not offer you anything, you may wish to consider such an option.

So, am I advocating some kind of

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

revolutionary movement to do away with law schools? Far from it! Instead, I think law school serves a number of useful purposes. Those purposes are the subject

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

of this article.

What I do have a problem with is the fact that law schools do very little to provide the practical training young lawyers need to actually get through

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

Following aspects would a

day of work at their first job, and that many of them try to pretend to the contrary.

Although there is much to say about what

dd to the challenges in developing combination products:

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

arget="_blank">law schools can do to improve, that is not what this article is about. Instead, I’m going to focus on the four significant benefits that I believe la

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

school offers to students, society in general and the legal profession:

First, the requirement that new lawyers graduate from law school se

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

rves a valuable purpose as a significant barrier to entry to the already saturated legal profession;

Second, law school ser

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

es to initiate you into the legal community – especially in the region where the law school is located. You will be blessed with three years and multiple o

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

Professional from academic institutions, pharmaceutical industries, health care indust

pportunities to develop important relationships with your classmates, professors, judges and attorneys;

Third, a law degree from a recogn

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

zed institution can be a valuable credential that will serve you throughout your life, whatever you do;

Finally, law school gives you time to thin

.

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

k.

[This article is continued in Law School Musings, Part 2 (Law School as a Barrier to Entry)]

This article may be freely reprinted or distr

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

Companies that provide selfless information through particip

buted in its entirety in any ezine, newsletter, blog or website. The author's name, bio and website links must remain intact and be included with every reproduction

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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