Regulatory Class

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

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

More about
Regulatory Class

  • Class purpose General learning

Learn faster with Brainscape on your web, iPhone, or Android device. Study Allison Mathes's Regulatory Class flashcards now!

How studying works.

Brainscape's adaptive web mobile flashcards system will drill you on your weaknesses, using a pattern guaranteed to help you learn more in less time.

Add your own flashcards.

Either request "Edit" access from the author, or make a copy of the class to edit as your own. And you can always create a totally new class of your own too!

What's Brainscape anyway?

Brainscape is a digital flashcards platform where you can find, create, share, and study any subject on the planet.

We use an adaptive study algorithm that is proven to help you learn faster and remember longer....

Looking for something else?

CII: IF1 Insurance Legal and Regulatory
  • 5 decks
  • 182 flashcards
  • 324 learners
Decks: Chapter 1 Risk And Insurance, Chapter 2 The Insurance Market, Chapter 5 Good Faith, And more!
Chapter 1: The Regulatory Environment
  • 10 decks
  • 536 flashcards
  • 2 learners
Decks: Regulatory Environment, Authorised And Approved Persons, The Conduct Of Business And Client Asset, And more!
Biotech Regulatory Environment
  • 13 decks
  • 199 flashcards
  • 2 learners
Decks: Biotech Industry Overview, Laws And Regulations Usda, Epa And Other Regulatory Agencies, And more!
Regulatory Framework for Business Tra...
  • 22 decks
  • 660 flashcards
  • 5 learners
Decks: Law On Obligations, Law On Contracts, Law On Sales, And more!
Make Flashcards