Answers - Legal

On a December 2006 article, I suggested this interpretation for the new Berkeley Nanotechnology Regulation:

1.

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 duty is to report, no more, no less

There are no exact standard as to the form of the report

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

Examples of combination products may in

General minimum disclosure standards may apply. Producers shall disclose anything within the boundaries of their present knowle

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

ge. Non disclosure may arise civil liability

It only applies to "manufactured" nanoparticles produced in the Juris

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

iction of the city of Berkeley. That means, natural nanoparticle or nanoparticle resulting from side-reaction could be exempted

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

Combination pro

from this regulation. This could also mean that nanoparticles being imported to Berkeley is outside the scope of this regulatio

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

The city cannot ban production and sale of nanoparticles by simply basing itself on the regulation. These are EPA's au

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

thority

The regulation does not regulate nanotechnology as a whole! It only regulates nanoparticle. Obviously, nanostru

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

tures are exempted from this regulation

There could be problems with regards to the definition of "nanoparticle"

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

l>

After exploring the issue further and conducted some discussion, I feel that some of the interpretation above is inadequate and/or in

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

orrect. With regards to point #2, I have obtained information that the standard reporting forms are currently being reviewed by industry

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

Following aspects would a

nd other stakeholders. So there might be a standard form of reporting. With regards to point #3, the report might need to be reviewed by

dd to the challenges in developing combination products:

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

n independent third party, a professional toxicologist or CIH, and this constitutes a part of the reporting form. My interpretation is in

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

ccurate with regards to point #4. Importation of nanoparticle to Berkeley will be subjected to the reporting obligation. With regards to

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

point #6, nanostructures may be subjected to reporting obligation if one of their axis is 100 NM or smaller (fit the definition of "nanop

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

rticle").

I fully agree with Mr. Hadithy that these precautionary approaches are required to protect the society from unknown harm. Ther

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

Professional from academic institutions, pharmaceutical industries, health care indust

is really nothing unusual with respect to the regulation, it is no different than normal chemical legislation which also require disclos

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

re. The only difference is that this one is applied to nanoparticles. As have been discussed in my other posts, there is inconclusive res

.

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

arch result on the harmful effect of nanoparticles to human.

According to some media reports, Berkeley’s approach might be followed by o

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

Companies that provide selfless information through particip

her cities. Cambridge is reported to have discussed the issue. Cambridge is also planning to follow Berkeley in regulating Nanotechnology

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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