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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 1,
Parts of a pma 2,
Parts of pma section summary sect...
73  cards
Regulatory Class - Parts of CMC
Parts of cmc section 1,
Parts of cmc section drug substan...,
Parts of cmc section drug substan...
10  cards
Regulatory Class - Parts of a NDA
Parts of a nda 1,
Parts of a nda administrative ite...,
Parts of a nda application summary 3
10  cards
Regulatory Class - Sept 26
Focus of fda review of ndas 1,
Adequate and well controlled stud...,
Using only foreign clinical data 3
55  cards
Regulatory Class - Oct 3
Drug substance 1,
Drug product 2,
Placebo 3
42  cards
Regulatory Class - Nov 7
What groups oversee advertising o...,
Label vs labeling 2,
Requirements for non promotional ...
47  cards
Regulatory Class - Parts of a NDA Annual Report
Parts of a nda annual report 1,
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 1,
Assessing the effects of the chan...,
Nda supplement major change 3
65  cards
Regulatory Class - Oct 31
Office of orphan products develop...,
Orphan drug designation 2,
Orphan drug financial incentives 3
47  cards
Regulatory Class - Nov 28
General requirements for exportin...,
Unapproved drug requirements for ...,
Exporting unapproved drugs 802 3
21  cards
Regulatory Class - Nov 14
Reasons for fda inspections 1,
What does fda inspect 2,
What may fda not inspect 3
40  cards
Regulatory Class - Dec 5
Different types of clinical trial...,
Risk based monitoring 2,
On site monitoring 3
17  cards

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Regulatory Class

  • Class purpose General learning

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