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Bill McBride has defeated former U.S. Attorney General Janet Reno in the Florida Primary election.

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

Reno, hated by many tried to repeat the Florida presidential vote controversies. Botched vote han

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

Examples of combination products may in

ling in the liberal counties of Broward and Miami-Dade were once again at the heart of the matter.

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

Unfortunately for Reno the vote was not close enough for a recount. Of course, Reno tried to pin

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

he blame on Governor Bush even though the election officials in both counties were democrats.

The

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

Combination pro

list of the objectionable action and inaction of Janet Reno is well documented. Most recently, a c

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

ourt ruling revealed the FBI botched more than 75 cases seeking espionage and terrorism warrants d

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

ring Janet Reno’s wrath.

Reno ordered the seizure of Elian Gonzalez at gunpoint and shipped him b

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

ck to Fidel Castro and his “daddy”. The only time I am aware of Reno speaking up for fathers, it w

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

as for a Cuban citizen.

Reno was accused of treason by Rep. James Trafficant. Trafficant has open

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

y blamed Reno and the Clinton Justice Dept. for his prosecution on corruption charges. He is the o

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

Following aspects would a

ly high ranking democrat to speak out against his party on a regular basis. He raised issues about

dd to the challenges in developing combination products:

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

the Clinton Administration’s handling of Waco, bribes involving the Chinese government and the de

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

th of Vince Foster. Predictably he was left out to dry by his fellow democrats.

Then there was th

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

attack on the Branch Davidians at Waco that ended in horrifying tragedy. There were 74 who died i

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 the inferno including children. Killed by agents acting under the authority of Janet Reno.

Ther

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

Professional from academic institutions, pharmaceutical industries, health care indust

were the repeated shielding of the Clintons from Independent investigators and Al Gore involving

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

is fundraising activities. The list goes on and on. A heavy hand where a light touch was needed an

.

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

d a turn of the head when there were serious matters, some which involved national security.

It i

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

Companies that provide selfless information through particip

scary to think of what kind of Governor Reno would have been. Thank God we won’t have to find out

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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