crystal_girl98

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Dear Members,
i have some questions to ask regarding drug regulation to clear some of my basic concepts...

1. why drug regulatory authority does not control patent issues?
2. why drug regulatory authority does not proactively control supplier of materials intended for manufacturing of drug product
3.why drug regulatory authority does not control pre IND and why drug regulatory authority regulate IND?

i will appreciate your answers,
Regards,
Humaira
 

Its Z

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It looks like a homework assignment.
 
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crystal_girl98

pharma-insane
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Thank you for the post. but i think your link does not relate to my questions.. i always face confusion when it comes to drug laws and regulating bodies.
 

IndustryPharmD

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Dear Members,
i have some questions to ask regarding drug regulation to clear some of my basic concepts...

1. why drug regulatory authority does not control patent issues?
2. why drug regulatory authority does not proactively control supplier of materials intended for manufacturing of drug product
3.why drug regulatory authority does not control pre IND and why drug regulatory authority regulate IND?

i will appreciate your answers,
Regards,
Humaira
And why are you asking?

1. by law
2. define "proactively"
3. think of history - when and why this regulation came about
 
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crystal_girl98

pharma-insane
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Apr 18, 2006
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my understanding to this thing is not very much.. that was the reason for asking.

1. first, i throught that drug regulatory authority is responsible for controlling patent issues, when i was discussing to a senior friend of mine, she said DRA doesn't control patent issues.. WHO ACTUALLY CONTROLS IT THEN?

2. i think that DRA doesn't control material supplies because they are concern with the final product. it would be irrational if they start controlling supplies too. the manufacturer will itself wish to have good quality supplies

3. pre IND is carried out on animals.. and DRA is not concern with animal health.

please rectify me if its not like that..
 

Farmercyst

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my understanding to this thing is not very much.. that was the reason for asking.

1. first, i throught that drug regulatory authority is responsible for controlling patent issues, when i was discussing to a senior friend of mine, she said DRA doesn't control patent issues.. WHO ACTUALLY CONTROLS IT THEN?

2. i think that DRA doesn't control material supplies because they are concern with the final product. it would be irrational if they start controlling supplies too. the manufacturer will itself wish to have good quality supplies

3. pre IND is carried out on animals.. and DRA is not concern with animal health.

please rectify me if its not like that..
Which country? The FDA is the DRA for the US, but I've never seen anyone refer to it so generically. It may be different in different countries. I'd think the US patent office controls US patents.:rolleyes:
 

owlegrad

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Which country? The FDA is the DRA for the US, but I've never seen anyone refer to it so generically. It may be different in different countries. I'd think the US patent office controls US patents.:rolleyes:
I once made this mistake on a report that was turned in for credit. I think I (mis)used this word about 20 times in a 500 word essay. Talk about embarrassing. :oops: