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It is also vital not to guess during a deposition. Frequently the other lawyer asks questions to which

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

the witness simply does not have the answer. It is important to remember that a deposition is not a m

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

Examples of combination products may in

ultiple choice test. You do not score points by occasionally guessing correctly. Stick to the facts an

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

d testify only to that which you personally know.

Every trial lawyer has seen his or her client’s cas

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

reduced in value by an incorrect guess. "I don’t know" is a fair answer if it is true. The time spent

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

Combination pro

preparing for the depositions will ensure that the witness does not have to rely on this answer too o

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

ften. "I don’t remember" is also fair if you truly don’t remember. Sometimes depositions are taken yea

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

s after the accident. It can be nearly impossible to recall the minute details attorneys routinely see

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

k during a deposition. Again, preparation will minimize the need to rely on this answer. It’s far bett

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

er to admit that you don’t know the answer to a question, or that you don’t recall the answer, than to

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

venture a guess.

Another key to a successful deposition is to know when to stop answering. Often the

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

Following aspects would a

defense lawyer uses the deposition as a "fishing expedition" in which he hopes to hook absolutely anyt

dd to the challenges in developing combination products:

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

hing of use to the defense case. That is why many questions that seem completely irrelevant to the acc

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

ident are asked. Believe it or not, this is generally permitted by the courts.

Since the other lawyer

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

is attempting to pick your mind, you must not make his or her job easier by responding to each questio

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 with a long, drawn out answer. If a question can fairly be answered with a "yes" or a "no," by all m

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

Professional from academic institutions, pharmaceutical industries, health care indust

eans do that and say no more until the next question is asked. Your lawyer may even tap you on the sho

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

lder or use a prearranged signal if your answers are getting too detailed. This signal lets you know t

.

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

o keep your answers brief. If you give the other lawyer enough ammunition, you increase the likelihood

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

Companies that provide selfless information through particip

that eventually he will find something to use against you. That is why brief answers are usually best

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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