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Summer always brings back memories for me of bbq’s, the ocean, Coney Island, Palisades Park, neighborhood and family get togethers. However, most of all, I think of all the fun the drive-in movies used to bring from chi

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

ldhood to adulthood.

During the bbq’s my dad always did the grilling and he did to perfection, nice and rare or medium rare steaks, burgers, those yummy hot dogs, that still couldn’t compare to the one’s we had at the ba

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

Examples of combination products may in

seball games we went to. The corn on the cob and the big garbage can of clams to steam or crabs to cook that we spent the day clamming or crabbing for. Stopping at the vegetable stand for the tomatoes, lettuce, radishes a

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

nd scallions but only because ours hadn’t come up yet in the garden. Once that happened we would have our own from “our garden”. My dad and I were in charge of the garden growing together.

The ocean, going on Friday’s w

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

ith my dad to work. He would finish early morning and off to Lido Beach we would go. We would spend all day there, till it was time for the drive home on the L.I.E. Once home my mom had a nice fish dinner (it was Friday n

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

Combination pro

ight and fish was a requirement, no meat) ready with veggies, and some potatoes, and pudding for dessert, of course. After all, it was Friday, the start of the weekend.

Weekends meant the Drive-in. When I was a kid, the

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

whole family would get in the car and make a night of it at the drive-in. We would have a light dinner and then all get ready to go to the movies. We got to sit in the back of the station wagon, play at the swing area bef

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

ore the movie, then the great cartoons would come on and we would all laugh. Before it was time for the movie, there was always an Intermission so we had time for those bathroom breaks and to get the “goodies” to watch th

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

e show with. Good n’ Plenty, Cracker Jack’s, Milk Duds, Raisinettes, Milky Way bars, Hershey Bars, Red Hots, Jawbreakers, Chunky’s, popcorn, hot dogs, pizza, we had so much to choose from. Some of my favorites were Good n

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

’ Plenty, Cracker Jack’s and Chunky bars. I can still hear that Good n’ Plenty and Cracker Jack jingle in my mind. Doesn’t help that I hear them when we play our Old Radio Shows. Although I must admit I did still remember

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

the words before then. Ah, the space all those jingles take up in my brain.

As I got older as most pre-teen and teenagers, you want to go with your friends to the drive-in. Even better getting your first car and then go

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

Following aspects would a

ing to the drive-in with your friends. Now there are some great memories. I can remember going with my girlfriends and having a blast. Meeting our friends there, all of us parking in the same row and yelling back and fort

dd to the challenges in developing combination products:

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

h at one another. Making plans of where to go after the movie. All of us scrambling to get home by curfews. Yes, we had curfews back then and we took them very seriously. If not, there were consequences.

Then, of course,

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

there were those great trips to Coney Island where my dad would check out the games they had for the season, make them up at home, practice and win me and my sister lots and lots of stuffed animals. Our bedrooms were cra

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

mmed with them. Oh, and the cotton candy and those delicious hot dogs. You haven’t lived until you had a hot dog at Coney Island.

Going to Palisades Park was always an adventure and back then they had the biggest roller

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

coaster around. Since my grandmother had 24 brothers and sisters I had a ton of cousins in New Jersey and our family get togethers were always fun. Plus all the cousins having a great time climbing trees, sneaking in the

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

Professional from academic institutions, pharmaceutical industries, health care indust

orchard next to my uncle Jim’s house and snitching some apples. Of course, when my uncle found out we were all reprimanded. Lots of great memories.

Our neighborhood get togethers usually centered around holidays. Memori

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

al Day, Independence Day, and Labor Day weekend. All of us would bring a dish and the bbq’s were all manned by the dads in the neighborhood. As kids we all got together and played baseball games, kick ball, dodge ball,

.

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

football. My dad was usually the coach, as he loved sports and was very good at them. Also helped that all the kids loved my dad. Many times there were fireworks and we got to hold the sparklers or get to light one of the

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

Companies that provide selfless information through particip

smaller fireworks.

The bbqs, trips to beach, Jersey, Palisades, family and neighborhood get togethers all bring back lots of great memories for me of Summer. So what does Summer remind you of?

DeFiore Enterprises, 200

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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