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Register"Primary concern" for regulators. Warning: excentric post [Regulatives / Guidelines]
Dear all,
another wacky post from me:
In this document from FDA (Ther. equivalent drugs 2011) FDA write "The primary concern from the regulatory point of view is the protection of the patient against approval of products that are not bioequivalent."
Strictly speaking, do you agree this is or shold be the entire truth?
I am inclined to say that it is equally important and in the interest of the wider public that FDA do not reject products that are truly bioequivalent. Do you agree?
Anyone out there starting think two steps ahead will of course start wonder here: if yes, then how could the regulators actually regulate for that? If a company does not have good data how can FDA safegaurd against rejection if the products nevertheless are equivalent? This is of course an important point especially since the burden of proof is traditionally on the applicant, but this is not the point I primarily wish to raise or discuss. That aspect only becomes practically important for later discussion if the answer to the philosophystic question above is "yes".
Lemme hear your thoughts, please.
EM
another wacky post from me:
In this document from FDA (Ther. equivalent drugs 2011) FDA write "The primary concern from the regulatory point of view is the protection of the patient against approval of products that are not bioequivalent."
Strictly speaking, do you agree this is or shold be the entire truth?
I am inclined to say that it is equally important and in the interest of the wider public that FDA do not reject products that are truly bioequivalent. Do you agree?
Anyone out there starting think two steps ahead will of course start wonder here: if yes, then how could the regulators actually regulate for that? If a company does not have good data how can FDA safegaurd against rejection if the products nevertheless are equivalent? This is of course an important point especially since the burden of proof is traditionally on the applicant, but this is not the point I primarily wish to raise or discuss. That aspect only becomes practically important for later discussion if the answer to the philosophystic question above is "yes".
Lemme hear your thoughts, please.
EM
Complete thread:
- "Primary concern" for regulators. Warning: excentric postElMaestro 2011-10-07 16:37
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- "Secondary concern" for regulators? Helmut 2011-10-07 18:12
- "Not our problem" for regulators ? Ohlbe 2011-10-07 18:18
Ing. Helmut Schütz