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I swear, never, ever in my life did I park in a handicapped spot, until I became handicapped, and got the plates. Never, NOT ONCE. It really ticked me off t

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

oo, when I saw some Mommy, or a podiatrist, with "Foot Doc" plates, wearing cowboy boots in NYC, blithely leap from his sportster and head for the mall leavi

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

Examples of combination products may in

g cars in handicapped spots. I tried to help-out, and was polite.

"Do you really think you should do that?" or "What if someone , who is handicapped needs t

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

at spot?"

Most people ignored me, pretended I wasn't talking to them just like people who cut the line at the movies do when they're caught. Since this

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

didn't work, I took a more proactive approach. Instead of talking, I'd yell until I either got a response, or someone else joined the fun. This usually wor

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

Combination pro

ed, and the creep would move the car, not without yelling back, but ultimately moved the car.

However, some people were clever, particularly if someone else

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

was watching.

"I am handicapped, but this isn't my car." " I lost the tag." "Mind your f---ing business."

However, this riposte always worked, " Oh, so

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

ry, then you won't mind if I call a cop. Do what you have to do, I'll wait 'til he shows-up. You'll get towed, but don't worry. The judge will throw it ri

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

ht out." When I dialed, they'd move the car. Nobody waited for the cop. It worked every single time.

Now, I am handicapped. Those spots are for me and yo

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

! Nonetheless, people still fight for them. These are my 2 favorite parking spot conversations. Both conversations happened when I pulled up to a handicappe

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

spot at the same time as another driver, one who didn't have the tags, or the plates, and I did.

She: "I was here first." Me: "It's a handicapped spot. S

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

Following aspects would a

ee my plates. You can't park here." She: "It never used to be a handicapped spot." Me: "It is now. You can't park here." She:" I'll just be a minute. Y

dd to the challenges in developing combination products:

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

u can wait right behind me."( I'm telling the truth) Me: "What's so important anyway?" She "Oh, Thank you." Me: " No , I said what's so important anyway?

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

She " I'm late for my nail appointment. Thank you. No one is nice anymore." Me: "Ma'am, please move your car. I'm calling the cops and I'm going to ask

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

hem to tow it" She: (now like a vampire) "I've never met such a rude, obnoxious..." ...or this one... He:' "C'mon, man. I'm late. I been waiting f'ever.

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

Me: "I know, It's a tough lot, but it's a handicapped spot. I'm handicapped." He: "C'mon, gimme a break (checks watch). Me: "No sorry, I hadda wait too.

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

Professional from academic institutions, pharmaceutical industries, health care indust

He: "Don't be a d---, I gotta get a crown fitted."

Crown fittings and fingernail appointments are important, but c'mon. Just in case you wondered who has

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

the audacity to park illegally in handicapped spots, it's people like the above. Ordinary people.

My modest solution is to buy my new militant Crip illegal

.

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

y parked in handicapped spot car window adjuster. It's really kust a tire iron, but with one good swipe it "cools off" the windows of illegally parked cars.

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

Companies that provide selfless information through particip

Think about it. It's a two-for-one special. One action, two good deeds: Put some money in my pocket, and perform a valuable public service at the same time

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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