...am I wrong? https://en.wikipedia.org/wiki/Inve
Post# of 36563
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Posted On: 06/02/2021 9:58:34 AM
...am I wrong?
https://en.wikipedia.org/wiki/Investigational_New_Drug
(...)Manufacturing Information includes composition, manufacturer, and stability of, and the controls used for, manufacturing the drug. Used to ensure that the company can adequately produce and supply consistent batches of the drug.
(...) Investigator information on the qualifications of clinical investigators, that is, the professionals (generally physicians) who oversee the administration of the experimental drug to the study subjects. Used to assess whether the investigators are qualified to fulfill their clinical trial duties
(...)Once an IND is submitted, the FDA has 30 days to object to the IND or it automatically becomes effective and clinical trials may begin
/SOME points are known to be well designed, or expected to go along well ...
/could the whole thing,though end up in a `progressive-adjusting-tentative submitting......or once-and-for good....
(I'd be glad to know of the well acquainted with this matter so to give us their view and summary)
https://en.wikipedia.org/wiki/Investigational_New_Drug
(...)Manufacturing Information includes composition, manufacturer, and stability of, and the controls used for, manufacturing the drug. Used to ensure that the company can adequately produce and supply consistent batches of the drug.
(...) Investigator information on the qualifications of clinical investigators, that is, the professionals (generally physicians) who oversee the administration of the experimental drug to the study subjects. Used to assess whether the investigators are qualified to fulfill their clinical trial duties
(...)Once an IND is submitted, the FDA has 30 days to object to the IND or it automatically becomes effective and clinical trials may begin
/SOME points are known to be well designed, or expected to go along well ...
/could the whole thing,though end up in a `progressive-adjusting-tentative submitting......or once-and-for good....
(I'd be glad to know of the well acquainted with this matter so to give us their view and summary)
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