An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
What does Ind mean in hospital?
Abbreviation for investigational new drug.
What is a treatment IND?
The treatment IND [21 CFR 312.34 and 312.35] is a mechanism for providing eligible subjects with investigational drugs for the treatment of serious and life-threatening illnesses for which there are no satisfactory alternative treatments. Treatment IND studies require prospective IRB review and informed consent.
Why is an ind required?
An IND is required when a drug is involved in a clinical investigation that is not exempt from the regulations. There is no intent to report the investigation to FDA as a well-controlled study in support of a new indication and no intent to use it to support any other significant change in the labeling of the drug.
What is the abbreviation of NDA?
Non-Disclosure Agreement (NDA)
What is IND approval?
IND Approval means the acceptance (or deemed acceptance) of the filing of an IND by the applicable Regulatory Authority. For purposes of clarity, acceptance (or deemed acceptance) of the filing of the foreign equivalent of an IND by the applicable Regulatory Authority in such country will be an IND Approval.
What is an IND IDE?
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical evaluation of devices that have not been cleared for marketing requires: an investigational plan approved by an institutional review board (IRB).
What does H & P stand for?
H and P: Medical shorthand for history and physical, the initial clinical evaluation and examination of the patient.
What is IND and NDA?
The Investigational New Drug (IND) application falls into the first category, while the New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and Biologics License Application (BLA) fall into the second category.
What is compassionate use protocol?
Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable
What is an expanded access IND?
Expanded access, sometimes called “compassionate use,” is the use of investigational new drug products outside of clinical trials to treat patients with serious or immediately life-threatening diseases or conditions when there are no comparable or satisfactory alternative treatment options.
What happens after IND approval?
Once an IND application is in effect, a drug manufacturer may ship the investigational new drug to the investigator(s) named in the application. An investigator may not administer an investigational new drug to human subjects until the IND application goes into effect.
What is needed for IND?
Filing an IND requires completion of 3 sets of forms: 1 detailing the study (FDA Form 1571), 1 providing information about the investigator and study site (FDA Form 1572), and 1 certifying that the study is registered in the national database of clinical trials (FDA Form 3674).
What is included in an IND?
The IND application must contain information in three broad areas: Animal Pharmacology and Toxicology Studies – Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).