Investigational New Drugs Flashcards
IND Regulations
21 CFR 312 cover procedures and requirements for INDs
Regulations also define the roles and responsibilities of FDA reviewers, IND sponsors and clinical investigators
Define IND
New drug or biologic used in a clinical investigation
IND application
Request to FDA for authorization to administer an investigational drug or biologic to humans
(Notice of Claimed Investigational Exemption for a New Drug)
Define Sponsor
Individual, company, academic institution, or other organization that takes responsibility for and initiates a clinical investigation
Define Investigator
Individual under whose immediate direction a drug is administered or dispensed
Define Sponsor-Investigator
Individual who both initiates and conducts an investigation
Do not include any person other than an individual
What is an IND
Drug that provide sufficient data to warrant study in humans
Must be secured prior to interstate shipment and administration of any new drug or biological product that is NOT an approved drug/biologic
Primary Objectives in Review
Safety and rights of subjects
Safety and efficacy of drug
Who submits INDs
Sponsor
Sponsor-Investigator
Other entities
Commercial INDs
Obtain marketing approval
Research INDs
Research-driven, no marketing approval
Emergency Use INDs
Only with a life-threatening situation that does not allow time for submission and review of IND
Exploratory IND
Study is conducted early in Phase 0
Involves limited human exposure
No therapeutic or diagnostic intent
Less preclinical data support needed
Treatment IND
Used to make promising new drugs available to desperately ill pts
Six exempt criteria
Not designed to support approval of a ned indication or a change in label
If study is not intended to support a significant change in the advertising
If the study does not involve a rounte of admin, dosage level or pt population that increases the risk
Study is conducted in compliance with IRB
Study is conducted in compliance with regulation regarding promotion and charging
It does not intend to invoke 21 CFR 50.24 (exception from informed consent requirements for emergency research)
IND Content Requirements
Cover sheet TofC Introduction Investigational Plan Brochure Protocols and supporting data CMC data Pharmacology and toxicology data Previous human experience Additional Information
IND Processing
FDA is required by regulation to respond within 30 days
If no issues, IND is considered in effect and sponsor may start the study
If issues cannot be resolved within 30 days, FDA can place the study on clinical hold
FDA Review
Safety Medical/clinical
Chemistry/Manufacturing/Control
Pharmacology/Toxicology
Statistical
Sponsor Responsibilities
Qualified investigator selection that conduct in accordance with protocols
Properly monitor
Maintain an effective IND
Inform FDA of new AE
Maintain adequate records, reporting and monitoring
Investigator Responsibilities
Agrees to personally supervise
Ensure investigation is conducted accordingly
Protects the rights, safety and welfare of study subjects, and obtain their informed consent
Controls investigation drugs
Report AE
Case histories uptodate
IND Holder Responsibilites
If an investigator submits an IND, they are responsible for following regulations for both a sponsor and investigator
Protocol Amendments
A new protocol
Changes to an existing
New investigator or update
Submitted before implementation and must be approved
Information Amendments
Clinical data
Pharmacology or toxicology data
CMC data
Notice of discontinuance of a clinical study
Annual Reports
Must be submitted within 60 days of the anniversary date that the IND went into effect
Info included: brief summary, update general investigational plan,
