Research Turn Around Times - IND

Question 1

21 CFR 312 (Investigational New Drug Applications): A sponsor or applicant must retain the records for how many years for a foreign clinical study not conducted under an IND if the study is submitted in support of an application for marketing approval?

Answer 1

2 years after agency decision on application

Question 2

21 CFR 312 (Investigational New Drug Applications): A sponsor or applicant must retain the records for how many years for a foreign clinical study not conducted under an IND if the study is submitted in support of an IND but not an application for marketing approval?

Answer 2

2 years after the submission of the IND

Question 3

21 CFR 312 (Investigational New Drug Applications): A person who ships a drug shall maintain adequate records showing the name and post office address of the expert to whom the drug is shipped and the date, quantity, and batch or code mark of each shipment and delivery. Records of shipments are to be maintained for a period of (blank) after the shipment. The person who ships the drug shall upon request from any properly authorized officer or employee of the Food and Drug Administration, at reasonable times, permit such officer or employee to have access to and copy and verify records required to be maintained.

Answer 3

2 year retention of drug shipment records

Question 4

21 CFR 312 (Investigational New Drug Applications): In all cases of expanded access, sponsors are responsible for submitting IND safety reports how often (when the IND or protocol continues for 1 year or longer) to FDA, ensuring that licensed physicians are qualified to administer the investigational drug for the expanded access use, providing licensed physicians with the information needed to minimize the risk and maximize the potential benefits of the investigational drug (the investigator’s brochure must be provided if one exists for the drug), maintaining an effective IND for the expanded access use, and maintaining adequate drug disposition records and retaining records?

Answer 4

1 year safety reports for expanded access

Question 5

21 CFR 312 (Investigational New Drug Applications): Beginning treatment— INDs. An expanded access IND goes into effect how long after FDA receives the IND or on earlier notification by FDA that the expanded access use may begin?

Answer 5

30 days after FDA receives IND for expanded access to start

Question 6

21 CFR 312 (Investigational New Drug Applications): The licensed physician or sponsor must explain how the expanded access use will meet the requirements and must agree to submit an expanded access submission within (blank) of FDA’s authorization of the use.

Answer 6

15 days to report emergency use of expanded access

Question 7

21 CFR 312 (Investigational New Drug Applications) IND safety reports: The sponsor must notify FDA and all participating investigators (i.e., all investigators to whom the sponsor is providing drug under its INDs or under any investigator’s IND) in an IND safety report of potential serious risks, from clinical trials or any other source, as soon as possible, but in no case later than how long after the sponsor determines that the information qualifies for reporting? In each IND safety report, the sponsor must identify all IND safety reports previously submitted to FDA concerning a similar suspected adverse reaction, and must analyze the significance of the suspected adverse reaction in light of previous, similar reports or any other relevant information.

Answer 7

15 calendar days for safety report

Question 8

21 CFR 312 (Investigational New Drug Applications) Submission of IND safety reports: The sponsor must submit each IND safety report in a narrative format or on FDA Form 3500A or in an electronic format that FDA can process, review, and archive. FDA will periodically issue guidance on how to provide the electronic submission (e.g., method of transmission, media, file formats, preparation and organization of files). The sponsor may submit foreign suspected adverse reactions on a Council for International Organizations of Medical Sciences (CIOMS) I Form instead of a FDA Form 3500A. Reports of overall findings or pooled analyses from published and unpublished in vitro, animal, epidemiological, or clinical studies must be submitted in a narrative format. Each notification to FDA must bear prominent identification of its contents, i.e., “IND Safety Report,” and must be transmitted to the review division in the Center for Drug Evaluation and Research or in the Center for Biologics Evaluation and Research that has responsibility for review of the IND. Upon request from FDA, the sponsor must submit to FDA any additional data or information that the agency deems necessary, as soon as possible, but in no case later than how long after receiving the request?

Answer 8

15 calendar days to respond to request for additional info

Question 9

21 CFR 312 (Investigational New Drug Applications): The sponsor must also notify FDA of any unexpected fatal or life-threatening suspected adverse reaction as soon as possible but in no case later than (blank) after the sponsor’s initial receipt of the information.

Answer 9

7 calendar days to report fatal or life-threatening suspected adverse reaction

Question 10

21 CFR 312 (Investigational New Drug Applications): If the results of a sponsor’s investigation show that an adverse event not initially determined to be reportable is so reportable, the sponsor must report such suspected adverse reaction in an IND safety report as soon as possible, but in no case later than (blank) after the determination is made.

Answer 10

15 calendar days for safety report

Question 11

21 CFR 312 (Investigational New Drug Applications): A sponsor shall within (blank) of the anniversary date that the IND went into effect, submit a brief report of the progress of the investigation

Answer 11

60 days after anniversary date progress of the investigation

Question 12

21 CFR 312 (Investigational New Drug Applications): An IND goes into effect (blank) after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold.

Answer 12

IND goes into effect 30 days after FDA receipt

Question 13

21 CFR 312 (Investigational New Drug Applications): An investigation may only resume after FDA (usually the Division Director, or the Director’s designee, with responsibility for review of the IND) has notified the sponsor that the investigation may proceed. Resumption of the affected investigation(s) will be authorized when the sponsor corrects the deficiency(ies) previously cited or otherwise satisfies the agency that the investigation(s) can proceed. FDA may notify a sponsor of its determination regarding the clinical hold by telephone or other means of rapid communication. If a sponsor of an IND that has been placed on clinical hold requests in writing that the clinical hold be removed and submits a complete response to the issue(s) identified in the clinical hold order, FDA shall respond in writing to the sponsor within (blank) of receipt of the request and the complete response. FDA’s response will either remove or maintain the clinical hold, and will state the reasons for such determination. Notwithstanding the (blank) response time, a sponsor may not proceed with a clinical trial on which a clinical hold has been imposed until the sponsor has been notified by FDA that the hold has been lifted.

Answer 13

30 days for FDA to respond to sponsor’s response of a clinical hold

Question 14

21 CFR 312 (Investigational New Drug Applications): Conversion of IND on clinical hold to inactive status. If all investigations covered by an IND remain on clinical hold for (blank), the IND may be placed on inactive status by FDA.

Answer 14

1 year from clinical hold to inactive status

Question 15

21 CFR 312 (Investigational New Drug Applications): The IND has remained on inactive status for (blank) before terminating the IND.

Answer 15

5 years to terminate an inactive IND

Question 16

21 CFR 312 (Investigational New Drug Applications): If no subjects are entered into clinical studies for a period of (blank) under an IND, or if all investigations under an IND remain on clinical hold for (blank), the IND may be placed by FDA on inactive status. This action may be taken by FDA either on request of the sponsor or on FDA’s own initiative. If FDA seeks to act on its own initiative, it shall first notify the sponsor in writing of the proposed inactive status. Upon receipt of such notification, the sponsor shall have (blank) to respond as to why the IND should continue to remain active.

Answer 16

IND to inactive status if 2 years no subjects or 1 year on clinical hold. The sponsor has 30 days to respond as to why the IND should continue to remain active.

Question 17

21 CFR 312 (Investigational New Drug Applications): An IND that remains on inactive status for (blank) may be terminated.

Answer 17

5 years to terminate an inactive IND

Question 18

21 CFR 312 (Investigational New Drug Applications): At least (blank) in advance of an end-of-Phase 2 meeting, the sponsor should submit background information on the sponsor’s plan for Phase 3, including summaries of the Phase 1 and 2 investigations, the specific protocols for Phase 3 clinical studies, plans for any additional nonclinical studies, plans for pediatric studies, including a time line for protocol finalization, enrollment, completion, and data analysis, or information to support any planned request for waiver or deferral of pediatric studies, and, if available, tentative labeling for the drug.

Answer 18

1 month in advance of meeting with FDA to submit background information

Question 19

21 CFR 312 (Investigational New Drug Applications): “Pre-NDA” and “pre-BLA” meetings. FDA has found that delays associated with the initial review of a marketing application may be reduced by exchanges of information about a proposed marketing application. The primary purpose of this kind of exchange is to uncover any major unresolved problems, to identify those studies that the sponsor is relying on as adequate and well-controlled to establish the drug’s effectiveness, to identify the status of ongoing or needed studies adequate to assess pediatric safety and effectiveness, to acquaint FDA reviewers with the general information to be submitted in the marketing application (including technical information), to discuss appropriate methods for statistical analysis of the data, and to discuss the best approach to the presentation and formatting of data in the marketing application. Arrangements for such a meeting are to be initiated by the sponsor with the division responsible for review of the IND. To permit FDA to provide the sponsor with the most useful advice on preparing a marketing application, the sponsor should submit to FDA’s reviewing division at least (blank) in advance of the meeting.

Answer 19

1 month in advance of meeting with FDA to submit background information

Question 20

21 CFR 312 (Investigational New Drug Applications) - Financial disclosure information: Sufficient accurate financial information to allow the sponsor to submit complete and accurate certification or disclosure statements. The sponsor shall obtain a commitment from the clinical investigator to promptly update this information if any relevant changes occur during the course of the investigation and for (blank) following the completion of the study.

Answer 20

1 year following completion of study for updates to financial information of investigator

Question 21

21 CFR 312 (Investigational New Drug Applications): A sponsor who determines that its investigational drug presents an unreasonable and significant risk to subjects shall discontinue those investigations that present the risk, notify FDA, all institutional review boards, and all investigators who have at any time participated in the investigation of the discontinuance, assure the disposition of all stocks of the drug outstanding and furnish FDA with a full report of the sponsor’s actions. The sponsor shall discontinue the investigation as soon as possible, and in no event later than (blank) after making the determination that the investigation should be discontinued. Upon request, FDA will confer with a sponsor on the need to discontinue an investigation.

Answer 21

5 days to discontinue a study when it is determined to discontinue it

Question 22

21 CFR 312 (Investigational New Drug Applications): A sponsor shall retain the records and reports required by this part for (blank) after a marketing application is approved for the drug; or, if an application is not approved for the drug, until (blank) after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.

Answer 22

2 year retention of records by sponsor after marketing application is approved or until 2 years after shipment and delivery of the drug if the application is not approved

Question 23

21 CFR 312 (Investigational New Drug Applications): An investigator shall retain records required to be maintained for a period of (blank) following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until (blank) after the investigation is discontinued and FDA is notified.

Answer 23

2 year retention of records by investigator after marketing application is approved or until 2 years after the investigation is discontinued if the application is not approved

Question 24

21 CFR 312 (Investigational New Drug Applications) - Financial disclosure reports: The clinical investigator shall provide the sponsor with sufficient accurate financial information to allow an applicant to submit complete and accurate certification or disclosure statements. The clinical investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for (blank) following the completion of the study.

Answer 24

1 year following the completion of study for investigator to report changes in financial disclosure

Question 25

21 CFR 312 (Investigational New Drug Applications): Unless FDA specifies a shorter period, charging for expanded access to an investigational drug for treatment use may continue for (blank) from the time of FDA authorization. A sponsor may request that FDA reauthorize charging for additional periods.

Answer 25

1 year for charging for expanded access