| a NEW DRUG OR BIOLOGIC that is used in clinical INVESTIGATION and in certain cases, for clinical treatment
is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug or biological humans
Is the FIRST FORMAL SUBMISSION of data concerning the POTENTIAL NEW THERAPY | Investigational New Drug (IND) |
| 1 INDs are filed by two groups:
2 There are two categories of INDs: | 1)
1 Manufacturers
2 health practitioners
2)
1 Commercial
2 Research |
| The IND is not approved right away by the FDA, sponsor must wait 1 __ following the filing of the application.
If during the initial 30 day period, the FDA has some safety concerns regarding initiating the clinical studies, it will issue a 2 __. Trials in human may not begin until the sponsor has resolved those safety concerns and the clinical hold has been lifted. | 1) 30 days
2 clinical hold |
| FDA IND Review Team | 1 Project Manager
2 Medical Officer
3 Statistician
4 Pharmacologist
5 Pharmakineticist
6 Chemist
7 Microbiologist
PMS PPCM |
| COORDINATES THE TEAM’S ACTIVITIES throughout the review process, and is the PRIMARY CONTACT for the sponsor. | Project Manager |
| REVIEWS ALL CLINICAL STUDY information and data BEFORE, DURING, and AFTER the TRIAL is complete. | Medical Officer |
| INTERPRETS CLINICAL TRIAL designs and DATA, and WORKS closely WITH MEDICAL OFFICER to evaluate protocols and safety and efficacy data | Statistician |
| REVIEWS PRECLINICAL STUDIES | Pharmacologist |
| Focuses on the DRUG’S ABSORPTION, DISTRIBUTION, METABOLISM, and EXCRETION PROCESSES. Interprets blood-level data at different time intervals from clinical trials, as a way to assess drug dosages and administration schedules. | Pharmakineticist |
| EVALUATES a drug’s CHEMICAL COMPOUNDS. Analyzes how a drug was made and its stability, quality control, continuity, the presence of impurities, etc. | Chemist |
| REVIEWS the DATA SUBMITTED, if the product is an ANTIMICROBIAL PRODUCT, to assess response across different classes of microbes. | Microbiologist |
| IND Contents: Accuracy and Completeness | 1 Cover letter/ Introduction
2 General Investigational Plan
3 Table of Contents
4 Investigator’s Brochure
5 Clinical Protocol(s)
6 Chemistry, Manufacturing, and Control Information
7 Summary of Previous Human Experience with the Investigational Drug
8 Additional Information
I Get The Investigator's CC Summary and Additional Infos |
| Cover letter/ Introduction
(STATE CONTENTS) | - Submission Identifier
- Brief explanation of the intended investigation
- Investigational new drug product’s name and drug substance (AI)
- P’cological class, structural formula
- Proposed formulation (dosage form), route of administration, objectives bad duration of clinical investigation
- Disease or condition under investigation
- IND manufacturer’s name and contact information (if applicable)
- Reference to an existing IND application (if applicable)
Summary: Brief explanation,
name of drug/chemical,
formula,
formulation,
condition tx,
manufacturer's info, reference |
| General Investigational Plan
(STATE CONTENTS) | - Rationale
- Indication
- General approach to be used to evaluate the drug
- Types of clinical trials
- Estimated number of patients to be studied
- Identification of serious or severe risks anticipated based on previous human or animal studies in this or relate drugs
RIGTEI |
| D. Investigator’s Brochure
(STATE CONTENTS) | - Brief description of the DRUG SUBSTANCE and THE FORMULATION, including the STRUCTURAL FORMULA, if known
- Summary of the PHARMACOLOGICAL and TOXICOLOGICAL EFFECTS of the drug in animals and, to the extent known, in humans
- Summary of the PHARMACOKINETICS and BIOLOGICAL DISPOSITION of the drug in animals and, if known, in humans
- Summary of INFORMATION RELATING TO SAFETY and EFFECTIVENESS in humans obtained from prior clinical studies
- Description of POSSIBLE RISKS and SIDE EFFECTS to be anticipated on the basis of prior experience with the drug under investigation or with related drugs, and of precautions or special monitoring to be done as part of the investigational use of the drug |
| expected to be DETAILED ENOUGH to permit FDA reviewers to LOCATE ITEMS in the application quickly and easily. | Table of Contents |
| This includes CLINICAL PROTOCOL and INFORMATION concerning the CLINICAL INVESTIGATOR, CLINICAL FACILITIES and the IRB | Clinical Protocol(s) |
| All needed information known about the drug must be documented in __.
This will eventually form the BASIS OF THE PACKAGE INSERT for the product. | Investigator’s Brochure |
