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assure accountability and product quality (i.e., that storage conditions, as defined in the protocol, for the IP were maintained during shipping, and the drug packaging was intact upon receipt). If the HCP administering the IP is not considered a sub-investigator, the investigator should ensure that they can obtain records regarding administration of the IP by requesting that the trial participants provide consent to allow access to medical records from their local HCPs involving trial-related data such as measuring vital signs, and results of evaluations of any symptoms or signs occurring with the infusion. Communicating the intent to request such records from the HCP in advance may facilitate this process. Consulting the appropriate FDA review division(s) on plans for alternative administration is also recommended as per Q9 above. Q18. If a trial participant is unable to receive the investigational drug from the trial site but the product is FDA-approved for other uses, can the patient or health care provider secure the product commercially or is this considered the sponsor charging for the investigational drug under 21 CFR 312.8? Can the sponsor reimburse trial participants for their out of pocket expenses in getting the drug commercially? If the product(s) under investigation in a clinical trial is FDA-approved, and the study does not require blinding, then local sourcing of the product(s) would be acceptable to FDA (e.g., by having the local physician write a prescription for the product instead of shipping the product 44 For the definition of a sub-investigator, see 21 CFR 312.3(b); for the requirement to list sub-investigators on the FDA Form 1572, see 21 CFR 312.53(c)(1). 45 As noted in the response to Q3 above, changes to a protocol necessary to eliminate an apparent immediate hazard to trial participants may be implemented before FDA and IRB review and approval (see 21 CFR 56.108(a)(4) and 21 CFR 312.30(b)(2)(ii)). Contains Nonbinding Recommendations 27 directly to the patient). FDA does not consider a trial participant’s commercial procurement of the study drug when unable to secure it from the trial site during the COVID-19 public health emergency to be a sponsor charging for an investigational drug under an IND per FDA regulations at 21 CFR 312.8. FDA also would not object if the sponsor reimburses the patient for any costs incurred by commercially purchasing the product or for charges related to an infusion. Per FDA regulations at 21 CFR 312.6, the immediate package of an investigational new drug intended for human use must bear a label with the statement “Caution: New Drug—Limited by Federal (or United States) law to investigational use.” FDA recognizes that a commercially obtained product will not have this statement on its container. In the setting of the COVID-19 public health emergency, where alternative arrangements are being made to provide an investigational agent to a participant who is unable to come to the trial site, FDA intends to exercise flexibility without sponsors needing to seek a waiver under 21 CFR 312.10 of the investigational labeling requirements under 21 CFR 312.6. Q19. Throughout the guidance, FDA recommends that sponsors consult with the review division for certain changes to ongoing clinical trials. For drugs and biologics, is this a reference to scheduling a Type A meeting? How should sponsors contact FDA regarding device clinical trials? As stated in our guidance for industry Best Practices for Communication Between IND Sponsors and FDA During Drug Development (December 2017), 46 review division regulatory project managers (RPMs) are the primary point of contact for communications between a sponsor and FDA. Both FDA and sponsors use various communication methods to focus discussions to exchange information and resolve issues efficiently. For example, telephone communication between a sponsor and FDA RPM may be more effective for time-sensitive matters. FDA staff try to respond to sponsor questions promptly, while balancing FDA public health priorities and other work obligations. Note that to ensure participant safety, responses to safety-related inquiries will be prioritized over other inquiries. More generally, FDA understands that many questions that will arise regarding changes in trial conduct due to COVID-19 will need to be addressed expeditiously. RPMs will work with sponsors to determine the best path forward to answer their questions for certain changes in an expedited manner. To discuss urgent issues related to IDEs managed in CDRH, sponsors should contact the lead reviewer. For IDEs managed in CBER, sponsors should contact the RPM. For FDA feedback on a proposed future IDE study, or regarding modifications to ongoing studies that are not urgent (such as a statistical analysis plan to address missing data), a Pre-Submission is recommended. For additional information on Pre-Submissions, please refer to FDA’s guidance for industry Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (May 2019). 47 For general questions regarding FDA policy on clinical trial conduct during the COVID-19 public health emergency, sponsors should contact Clinicaltrialconduct-COVID19@fda.hhs.gov. 46 Available on the FDA guidance web page. 47 Available on the FDA guidance web page. 

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