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§ 312.31 Information amendments.
(a) Requirement for information amendment. A sponsor shall report in an information amendment essential information o… +
§ 312.33 Annual reports.
A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief report of the progress o… +
§ 312.33 Annual reports.
A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief report of the progress o… +
§ 312.33 Annual reports.
A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief report of the progress o… +
§ 312.38 Withdrawal of an IND.
(a) At any time a sponsor may withdraw an effective IND without prejudice.
(b) If an IND is withdrawn, FDA shall be so … +
§ 312.40 General requirements for use of an investigational new drug in a clinical investigation.
[…]
(c) A sponsor may ship an investigational new dr… +
§ 312.40 General requirements for use of an investigational new drug in a clinical investigation.
[…]
(b) An IND goes into effect:
(1) Thirty days aft… +
§ 312.42 Clinical holds and requests for modification.
(a) General. A clinical hold is an order issued by FDA to the sponsor to delay a proposed clini… +
§ 312.44 Termination.
(a) General
[…]
(b) Grounds for termination —
[…]
(c) Opportunity for sponsor response.
[…]
(d) Immediate termination of IND
[…]… +
§ 312.44 Termination.
[…]
(d) Immediate termination of IND
(d) Immediate termination of IND. Notwithstanding paragraphs (a) through (c) of this sectio… +
§ 312.45 Inactive status.
(a) If no subjects are entered into clinical studies for a period of 2 years or more under an IND, or if all investigations… +
§ 312.50 General responsibilities of sponsors.
Sponsors are responsible for selecting qualified investigators, providing them with the information the… +
§ 312.52 Transfer of obligations to a contract research organization.
(a) A sponsor may transfer responsibility for any or all of the obligations set … +
§ 312.53 Selecting investigators and monitors.
[…]
(viii) A list of the names of the subinvestigators (e.g., research fellows, residents) who will be … +
§ 312.53 Selecting investigators and monitors.
(a) Selecting investigators
[…]
(b) Control of drug.
[…]
(c) Obtaining information from the investigato… +
§ 312.53 Selecting investigators and monitors.
(c) Obtaining information from the investigator. Before permitting an investigator to begin participati… +
§ 312.53 Selecting investigators and monitors.
[…]
(c) […]
(vi) A commitment by the investigator that he or she:
(a) Will conduct the study(ies) in ac… +
§ 312.53 Selecting investigators and monitors.
[…]
(c) […]
(vi) A commitment by the investigator that he or she:
(a) Will conduct the study(ies) in ac… +
§ 312.53 Selecting investigators and monitors.
[…]
(b) Control of drug. A sponsor shall ship investigational new drugs only to investigators participa… +
§ 312.53 Selecting investigators and monitors.
[…]
(d) Selecting monitors. A sponsor shall select a monitor qualified by training and experience to mo… +
