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Regulatory Class

This class was created by Brainscape user Allison Mathes. Visit their profile to learn more about the creator.

By: Allison Mathes
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Decks in this class (12)

Regulatory Class - Oct 10
Parts of a 510 k,
Parts of a pma,
Parts of pma section summary section
73  cards
Regulatory Class - Parts of CMC
Parts of cmc section,
Parts of cmc section drug substance,
Parts of cmc section drug substan...
10  cards
Regulatory Class - Parts of a NDA
Parts of a nda,
Parts of a nda administrative items,
Parts of a nda application summary
10  cards
Regulatory Class - Sept 26
Focus of fda review of ndas,
Adequate and well controlled studies,
Using only foreign clinical data
55  cards
Regulatory Class - Oct 3
Drug substance,
Drug product,
Placebo
42  cards
Regulatory Class - Nov 7
What groups oversee advertising o...,
Label vs labeling,
Requirements for non promotional ...
47  cards
Regulatory Class - Parts of a NDA Annual Report
Parts of a nda annual report,
Parts of a nda annual report labe...,
Parts of a nda annual report cmc ...
6  cards
Regulatory Class - Oct 24
Making changes to an nda,
Assessing the effects of the change,
Nda supplement major change
65  cards
Regulatory Class - Oct 31
Office of orphan products develop...,
Orphan drug designation,
Orphan drug financial incentives
47  cards
Regulatory Class - Nov 28
General requirements for exportin...,
Unapproved drug requirements for ...,
Exporting unapproved drugs 802
21  cards
Regulatory Class - Nov 14
Reasons for fda inspections,
What does fda inspect,
What may fda not inspect
40  cards
Regulatory Class - Dec 5
Different types of clinical trial...,
Risk based monitoring,
On site monitoring
17  cards

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Regulatory Class

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