Social Space - Travel and Leisure

When you think of New York City, what comes to mind immediately? Times Square? Broadway? Fifth Avenue? If you are in New York City for the first time, you have to see Times Square, where they drop that famous ball on New Year’s Eve whil

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

e the legendary Dick Clark spins rock n’ roll, and a million revelers party until morning. Yes, you have to see a Broadway show or two, or even three if you can afford it. And of course, you need to take that walk down Fifth Avenue goin

; 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 north from 42nd Street, stopping at Rockefeller Center, St. Patrick’s Cathedral, and Tiffany’s, Gucci, Chanel and Bendel’s. Go a little bit north, past the entrance of Central Park, to visit the Metropolitan Museum of Art, and the Gugg

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

nheim Museum. Lastly, go play in the park, have brunch at Tavern on the Green, and go to the Museum of Natural History, made famous by the recent hit film “Night at the Museum”. If this is your first time in New York City, and you are o

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

nly there for a week, this will keep you busy, and exhausted. But to really see the history and taste New York’s flavor, you have to go off that “beaten track”!

And the good news is that you don’t have to go far, or spend a lot of mone

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

Combination pro

y. First of, don’t hail a cab -- get down into the subway, the way the locals do. Yes the subway--it’s cleaner, safer, and more comfortable than ever. Just avoid the crush--- from 7 to 9:30 in the morning, and from 4:30 in the afternoon

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

ntil 7 at night-- and you will most likely get a seat, and plenty of elbow room. Subway travel, which averts congestion and traffic lights, is the quickest way to get around. So equip yourself with a subway map and an unlimited one-week

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

Metrocard pass (which is good on the buses too) and you are on your way to the real New York City. First, go to the West Fourth Street stop. When you get to street level, you will be in one of the most legendary sections of New York. Ca

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

lled Greenwich Village, this was the home of liberalism. In the early 1900s, the “Village” was the center of free thinking and progressive writing. It was here that the Triangle Shirtwaist Fire of 1911 spawned the workers rights movement

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

The centerpiece is New York University, and Washington Square Park with its famous arch. Many beatniks, hippies, and radicals formulated their protest plans or wrote their avant-garde manuscripts and manifestoes here by that arch. Walk

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

east from here, and pass Astor Place, where Lincoln made a famous campaign speech and mobs rioted in the mid-1800s because an Englishman replaced an American actor in a play at the Astor Place Theater Keep going through famous St. Ma

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

Following aspects would a

rk’s Place until you hit Bowery. It was here that the Ramones got their start at the now-defunct punk-music club, CBGB’s.

At the stop on Canal Street and Broadway, is Chinatown. Have tea and dim sum (appetizers), wheeled around on cart

dd to the challenges in developing combination products:

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

. Point to your choice and, when you are finished, your plates are counted to compute the bill. At Prince or Spring St, you are in SoHo, once an art district, now a place to shop designer labels, like Prada. If you have funkier tastes, j

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

ust go south instead and you will be in the Lower East Side, around Delancey Street (as in the street Amy Irving crossed in the movie). Once the landing place of thousands of Jewish immigrants around the turn of the twentieth century, t

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

his is now a place for trendy boutiques and hip restaurants. West of here, down Mott and Mulberry, is Little Italy. Remember the scene in The Godfather when Michael meets with rival mobsters in a Little Italy restaurant, and stashes a g

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

n in the bathroom? Well, don’t look for guns, but you will find cannoli, lasagna, gelato, and, in September, the world-famous Feast of San Gennaro. South of SoHo is Tribeca, home of the renowned film festival started by Robert Deniro.

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

Professional from academic institutions, pharmaceutical industries, health care indust

And further south from there, catch a glimpse of Ground Zero and the former site of the Twin Towers before construction of the Freedom Tower reminds us that life does indeed go on and on, and on. The world changes, so does New York City.

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

So don’t limit yourself to the tourist route. Hop that subway to the places where you can still see some history. Some of the tenements are still there, even if the “hudded masses” of yesteryear are now masses of hipsters. Sip an e

.

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

presso in Little Italy or sniff the fresh fish in Chinatown. Sit under a tree in Washington Square Park, that could have inspired Jack Kerouac and his group of beat poets. Think about the 146 young immigrant girls who, a block away in 1

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

Companies that provide selfless information through particip

911, died in the tragic fire, that inspired the formation of the garment workers unions. When you go off the beaten track in New York City, you feel so much history, culture and soul of the people who have lived, died, and dreamed there

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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