Actual - Legal

Food and Drug Administration (FDA) - http://www.fda.gov:

The FDA is probably most thought of when the word “recall” comes up. It is obvious that the FDA deals with food and drug issues, but they are also in charge of tes

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

ting, monitoring and recalling medical devices (pacemakers, contact lenses...), animal feed, cosmetics, and products with the potential to cause health-related side effects, such as cell phones and lasers. Although the FDA is in charge of

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

Examples of combination products may in

“food,” they also share that responsibility with the next federal agency…

United States Department of Agriculture (USDA) - http://www.usda.gov:

The USDA was founded by President Abraham Lincoln in 1862, and has been in

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

olved in a variety of agricultural initiatives ever since. Not only is the USDA steward to our nation's 192 million acres of national forests, and providing food to children through school breakfast and lunch programs, but the agency is a

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

lso responsible for the safety of meat, poultry (including egg), milk and fish products. These responsibilities often encompass the study of pesticide use, which overlaps with the next governmental recall arm...

Environmental Pro

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

Combination pro

tection Agency (EPA) - http://www.epa.gov:

The EPA, in addition to the many other responsibilities involved in protecting our environment, are charged with the recalling of products that threaten to harm humans, animals, or 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

nvironment in which we live. For instance, recently the EPA ordered five national retail chains to recall a brand of spray confetti string which contained banned hydro chlorofluorocarbons blamed for depleting the ozone layer. This very sa

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

me product could have also been recalled by another government agency, however, for its highly flammable contents, which are often sprayed over people at birthday parties near flaming candles. The agency that would be responsible for this

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

type of recall is...

Consumer Product Safety Commission (CPSC) - http://www.cpsc.gov:

The CPSC is in charge of protecting the public from "unreasonable risks of serious injury or death from more than 15,000 types of co

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

sumer products under the agency's jurisdiction". They handle recalls for a host of potentially dangerous products, from toys with choking hazards to heaters with propensity to start a fire. Most products with a defect of some kind will fi

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

nd their way into the CPSC database of recalled consumer products. But if that product has wheels and an engine, or is a part of a product that has wheels and an engine, you might be better off researching at the next governmental agency.

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

Following aspects would a

..

The National Highway Traffic Safety Administration (NHTSA) - http://www.nhtsa.dot.gov:

The NHTSA was established to reduce deaths, injuries and economic losses resulting from motor vehicle crashes. They set and enfor

dd to the challenges in developing combination products:

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

e safety standards for motor vehicles and vehicle parts, and provide studies and reports on anything related to motor vehicle use, from tires and seatbelts, to SUVs and cell phone use while driving. If you want to know if the used car you

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

just purchased has any defective auto parts, the NHTSA database is a good start. However, if you just purchased a used boat, the following agency is better suited for your needs...

US Coast Guard - http://www.uscg.mil:

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

You probably don’t think of product recalls when someone mentions the Coast Guard. However, in addition to their duties to patrol America’s coast line and assist those in distress, the Coast Guard also tests, reports on, and recalls boat

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

, boating parts, and marine safety devices like flares and life jackets. But good luck finding recall information on the Coast Guard’s website!

As you can see, the responsibilities of each agency overlap to some degree with other agencie

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

Professional from academic institutions, pharmaceutical industries, health care indust

s. Furthermore, issuing recall alerts is only a small part of each organization’s responsibility. This is why is can be difficult, time-consuming and frustrating to locate the information you’re looking for among these six websites. Lucki

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

ly, this problem has been remedied by an ex-journalist with a passion for social corporate responsibility and citizen journalism…

US Recall News – http://www.usrecallnews.com:

US Recall News is a non-governmental websit

.

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

that brings together recall alerts from each of the six major government agencies listed above, and separates them into various categories. The alerts are then archived at the end of each month, and remain searchable from the website. In

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

Companies that provide selfless information through particip

addition to these recall alerts, US Recall News also has a blog that serves as an editorial opinion vehicle to further discuss major issues in the world of corporate responsibility and product safety: http://www.usrecallnews.com/blog.htm

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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