IND Filing
What does the three-letter acronym, used for a new drug test/existing drug that is being used to support a new indication, significant labeling change, or other major change in use stand for.
Investigational New Drug
What does the three-letter federal agency that regulates drugs, biologics, and medical devices in the United States stand for.
Federal Drug Administration (FDA)
Number of clinical trials needed to approve a therapetic product
4
This acronym stands for Good Manufacturing Practice
GMP
A company has an active U.S. IND and wants to begin a clinical trial in Denmark. Can it proceed using only its U.S. IND?
No - it must be receive authorization in Denmark through the EU clinical trial framework.
3 types of information present in every IND.
- Preclinical data
- Manufacturing data
- Clinical protocol and investigator qualifications
This FDA center is primarily responsible for regulating human drugs.
CDER (Center for Drug Evaluation and Research)
This document explains study risks and procedures to participants before they voluntarily agree to participate.
Informed consent
This type of study compares an investigational treatment with an inactive substance that looks like the treatment.
Placebo controlled study
Operation Trialblazer has this type of pre-IND review submission
Type of IND study used for unapproved drug or approved drug in new patient population
Investigator IND
Recently launched U.S Department of Health and Human Services imitative supported by the FDA program to accelerate early stage clinical development through measures such as expedited IND pilot program, clarified Phase 1 CMC requirements, etc.
FDA TrialBlazer
This term describes an unfavorable medical occurrence in a clinical trial participant, whether or not it is caused by the investigational drug.
Adverse effect (AE)
This term describes the length of time a drug product is expected to remain within established specifications when stored under defined conditions.
Shelf life
The FAST-EU regulatory integrates the FDA and what other agency.
IRB
The regulatory requirements for INDs are defined covering scope, definitions, content, safety reporting, amendments, and investigator responsibilities in the CFR
21 CFR Part 312
This is the type of FDA action that delays or suspends a proposed or ongoing clinical investigation.
Clinical hold
This document describes the planned methods for analyzing clinical trial data, including endpoints and statistical tests.
Statistical Analysis Plan (SAP)
This term describes the amount of product produced during a manufacturing run.
Batch yield
Australias CTN (Clinical Trial Notification) scheme is an ethics-based regulatory scheme governed by which Australian ethics committee.
Human Research Ethics Committee (HREC)
How many days an IND becomes effective after approval from FDA
30 days
How many days an IND becomes effective after approval from FDA
30 days
This clinical trial phase typically provides initial evidence of effectiveness and continues evaluating safety in patients with the condition.
Phase 2
Under 21 CFR 312.38, this regulatory action ends all clinical investigations under an IND and generally requires a final report.
IND withdrawal
First in Human Trials in this East Asian country has a recognized investigator issued trial (IIT) framework
Japan