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The truth of the matter is free government grants are not exactly free. These supposedly free government grants come with a price tag too. Free government gran

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

ts will require you to fulfill certain obligations. Not being able to fulfill them will get you penalties, sometimes severe.

Free government grants are usuall

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

Examples of combination products may in

awarded to projects proposed by organizations that are perceived to redound to benefit the community. Examples of these projects that received free governmen

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

t grants are: street paving project in the neighborhood, a program to re-train displaced workers in the state, project to bring new businesses to a depressed 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

ea, etc.

Aside from benefiting the community, the project that merits free government grants must:

Meet strict oversight performance standards.

Account for

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

Combination pro

ll project expenditures and be subject to detailed audits conducted by the government annually.

Spend all grant funds. Money left must go back to the Treasury

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

.

Develop, approve and carry out all detailed programs exactly as stated in the grant application, any changes must be approved by the government before imple

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

entation.

Complete al project phases on time.

Complete the project successfully.

Failure to comply with the above requirements could result in consequences

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

rom economic sanction to imprisonment in cases of improper utilization of public funds.

Free government grants are usually awarded to federal agencies, states

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

, cities, colleges, universities and research organizations. Individuals seldom get free government grants because of the complexities involve in preparing ap

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

lications for free government grants. As a matter of fact, those who actively pursue grants often spend money to hire staffs that would focus on applying and a

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

Following aspects would a

ministering free government grants alone.

The projects proposal coming from agencies, President, states, cities, etc will be decided by congress. Congress ha

dd to the challenges in developing combination products:

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

s the final say as to how much free government grants’ money the program will get.

Upon approval of the federal budget, funds for free government grants proje

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

ts are available and announced in the Federal Register for the entire year. Projects that can avail of free government grants will appear in the Catalog of Fe

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

eral Domestic Assistance (CFDA). The CFDA lists all free government grants and assistance programs managed by 57 federal agencies. CDFA’s website is http://ww

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

w.cfda.gov/.

Eligible persons or organizations with plans that fall under the different project categories approved by congress may apply to the concerned dep

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

Professional from academic institutions, pharmaceutical industries, health care indust

rtment to get a portion of the total free government grants allocation under that project. For instance, Department of Housing and Urban Development (HUD) has

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

een allocated by congress with $22 million to develop “Public and Indian Housing Drug Elimination Program”. If you think that your project will contribute to

.

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

this project you may apply to HUD to get a portion of the $22 million free government grant.

If you have the stamina to go through the rigors of preparing the

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

Companies that provide selfless information through particip

application for free government grants then by all means do so. Free government grants are available at your disposal. Use these free government grants wisely

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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