Advice You - Business

I have written quite a number of articles regarding the danger of toxins. Toxins have long been recognized as one of the main causes of the obesity problem here

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

in North America.

However I read an interesting article from the BBC today, this shows Toxins are not only in the air we breathe , but are been placed in our fo

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

Examples of combination products may in

ds and cosmetics. ………

US checks toothpaste for toxins

Toothpaste is the latest Chinese export to raise safety concerns Health officials in the United States s

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

ay they are checking all shipments of toothpaste imported from China for contamination with toxic chemicals. Panama and the Dominican Republic have reported fi

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

ding diethylene glycol, a chemical used in engine coolants, in toothpaste from China.

The toothpaste scare is the latest involving products from China. Earlie

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

Combination pro

this year, contaminated pet food ingredients killed a number of cats and dogs in North America.

The toxic chemical, melamine, was found in wheat gluten exports

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

from China for use in pet food, prompting a recall of at least 100 pet food brands. The tainted wheat gluten was even thought to have made its way into livest

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

ck feed. Low-cost substitute Cough syrup containing diethylene glycol originating from China killed more than 50 people in Panama last year.

The New York Ti

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

es said a Chinese chemical maker had sold the industrial-grade chemical as glycerine, which is often used as a moistener in products from toothpaste to soap and

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

cosmetics.

CHINESE FOOD SCARES
May 2007 China probes reports that contaminated toothpaste was sent to Central America
March 2007 Melamine is found in

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

wheat gluten exports from China for use in pet food, prompting a recall of at least 100 pet food brands
Nov 2006 A dye farmers fed to ducks to make their e

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

Following aspects would a

gs look fresher is found to contain cancer-causing properties and 5,000 ducks are culled
August 2006 About 40 people in Beijing contract meningitis after e

dd to the challenges in developing combination products:

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

ating partially cooked snails at a chain of restaurants.

Diethylene glycol is sometimes used as a low-cost substitute for glycerine and Chinese toothpaste maker

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

have said small amounts of the chemical are harmless in toothpaste. "We are going to be sampling and testing all shipments of toothpaste that come from China,

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

said Doug Arbesfeld, a spokesman for the US Food and Drug Administration. The FDA says China is the second-largest exporter of toothpaste to the US after Cana

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

da. Food safety investigators in Panama said two brands of toothpaste were imported illegally from China through a free-trade zone.

Chinese officials say they

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

Professional from academic institutions, pharmaceutical industries, health care indust

are investigating the claims. The Dominican Republic and Panama have pulled thousands of tubes of Chinese toothpaste brands Excel and Mr Cool from store shelve

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

.

Beijing recently pledged to clean up its tainted food and drug industry after the series of safety scares. The subject was raised by the US in bilateral trade

.

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

talks this week. The former head of China's State Food and Drug Administration is facing trial, accused of taking large bribes to approve untested medicines.

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

Companies that provide selfless information through particip

End of article.

Wow, some people will risk thousands and thousands of lives just for a few dollars, these sort of people should receive a very severe punishment

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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