|
Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of November 24, 2009
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION
Subpart A--GENERAL PROVISIONS
|
| Definitions and interpretations. |
|
|
| Labeling of an investigational new drug. |
|
|
| Promotion of investigational drugs. |
|
|
| Charging for investigational drugs under an IND. |
|
Subpart B--INVESTIGATIONAL NEW DRUG APPLICATION (IND)
|
| Phases of an investigation. |
|
|
| General principles of the IND submission. |
|
Subpart C--ADMINISTRATIVE ACTIONS
|
| General requirements for use of an investigational new drug in a clinical investigation. |
|
|
| Comment and advice on an IND. |
|
|
| Clinical holds and requests for modification. |
|
Subpart D--RESPONSIBILITIES OF SPONSORS AND INVESTIGATORS
|
| General responsibilities of sponsors. |
|
|
| Transfer of obligations to a contract research organization. |
|
|
| Selecting investigators and monitors. |
|
|
| Emergency research under 50.24 of this chapter. |
|
|
| Review of ongoing investigations. |
|
|
| Recordkeeping and record retention. |
|
|
| Inspection of sponsor's records and reports. |
|
|
| Disposition of unused supply of investigational drug. |
|
|
| General responsibilities of investigators. |
|
|
| Control of the investigational drug. |
|
|
| Investigator recordkeeping and record retention. |
|
|
| Inspection of investigator's records and reports. |
|
|
| Handling of controlled substances. |
|
|
| Disqualification of a clinical investigator. |
|
Subpart E--DRUGS INTENDED TO TREAT LIFE-THREATENING AND SEVERELY-DEBILITATING ILLNESSES
|
| Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses. |
|
|
| Focused FDA regulatory research. |
|
|
| Active monitoring of conduct and evaluation of clinical trials. |
|
|
| Safeguards for patient safety. |
|
Subpart F--MISCELLANEOUS
|
| Import and export requirements. |
|
|
| Foreign clinical studies not conducted under an IND. |
|
|
| Availability for public disclosure of data and information in an IND. |
|
|
| Address for correspondence. |
|
Subpart G--DRUGS FOR INVESTIGATIONAL USE IN LABORATORY RESEARCH ANIMALS OR IN VITRO TESTS
|
| Drugs for investigational use in laboratory research animals or in vitro tests. |
|
Subpart I--EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE
|
| Requirements for all expanded access uses. |
|
|
| Individual patients, including for emergency use. |
|
|
| Intermediate-size patient populations. |
|
|
| Treatment IND or treatment protocol. |
|
|
