FDA

Question 1

NDA

Answer 1

New Drug Application

Question 2

Center for Drug Evaluation

Answer 2

CDER

Question 3

CTA

Answer 3

Clinical Trial Application
Essential for obtaining approval to conduct trials

Question 4

BLA

Answer 4

Biologics license Application to FDA or EMA

Question 5

GMP

Answer 5

Good manufacturing processes

Question 6

Center for Biologics Evaluation & Research

Answer 6

CBER

Question 7

Stages of Development

Answer 7

Preclinical
Clinical Trials Phases 1,2,3

Question 8

ICH

Answer 8

International Council for Harmonization of Technical Requirements

Drug safety
Quality
Efficacy
Multinational
Risk management

Question 9

EMA

Answer 9

EUROPEAN medicinal Agency

Question 10

IND

Answer 10

Investigational new drug

Question 11

RMP

Answer 11

Risk Management Plan

Question 12

CTA

Answer 12

Clinical Trial Application
Outside of USA

Question 13

Phase 1

Answer 13

First in Human
Evaluate safety and dosage in a small group

Question 14

Phase 2

Answer 14

Proof of concept
Dose range finding
Efficacy and side effects with targeted condition

Question 15

Phase 3

Answer 15

Large scale testing of effectiveness and long term side effects

Question 16

Phase 4

Answer 16

Post marketing studies post approval

Question 17

EPAR

Answer 17

European Public Accessment Report

Question 18

CNS

Answer 18

Central Nervous System

Question 19

EU CTR

Answer 19

European Clinical Trial Regulation

Question 20

eCTD

Answer 20

Electronic common technical document

Question 21

MAA

Answer 21

Marketing Authorization
Application internationally

Question 22

Fast Track
Breakthrough
Accelerated Approval
Priority Review

Answer 22

FDA Accerlated Approval
Break through

Any Drug developed to treat a with unmet needs.

Or Drug needs to show advantage of current offering

Question 23

Orphan Drug

Answer 23

A rare disease, less than 10,000 people affected.

In USA 200,000

Question 24

ICF

Answer 24

Informed Consent Form for patients within study-

Question 25

Wave 2

Answer 25

2nd batch of Countries for submissions

Question 26

IB

Answer 26

Investigator brochure

Question 27

IMPD

Answer 27

Investigational Medicinal Product Dossier

Question 28

PMR

Answer 28

Post Marketing Requirements

Question 29

Chemistry Manufacturing Controls

Answer 29

CMC

Question 30

Cancer Drug approval Process

Answer 30

Early Phase Late Phase FDA Review of NDA

Question 31

CRO

Answer 31

Clinical Research Organization

Question 32

eDMS

Answer 32

Electrónic Data Management System Veeva

Question 33

CRO

Answer 33

Contract Research Organization

Question 34

SAP

Answer 34

Statistical Analysis Plan

Question 35

Global Regulatory Lead

Answer 35

GRL