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                Investigational New Drug Applications (INDs) for CBER-Regulated  Products

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          Investigational New Drug Applications (INDs) for CBER-Regulated  Products
          Recommendations for Investigational COVID-19 Convalescent PlasmaInvestigational New Drug Applications (INDs) for CBER-Regulated  Products Recommendations for Investigational COVID-19 Convalescent Plasma
  
  	
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    Print**January 10, 2022**

FDA issued an EUA for convalescent plasma on August 23, 2020 and has subsequently reissued this EUA with revisions.



FDA has issued a new guidance to provide recommendations to health care providers and investigators on the use of COVID-19 convalescent plasma under the EUA or investigational convalescent plasma under an IND during the public health emergency. The guidance also provides recommendations to blood establishments on collection. The guidance supersedes the guidance of the same title issued in February 2021 (previous versions January 2021, November 2020, September 2020, May 2020, and April 2020).

The guidance provides recommendations on the following:

pathways for use of investigational convalescent plasma
	collection of convalescent plasma
	record keepingBecause convalescent plasma for the treatment of COVID-19 has not yet been approved for use by FDA, it is an investigational product. As such, its administration must be under the EUA or an IND.  FDA does not collect convalescent plasma or provide convalescent plasma.  Health care providers or acute care facilities should obtain convalescent plasma from an FDA registered or licensed blood establishment.

Excerpts from the guidance document are provided below.

**Background**

On August 23, 2020, FDA issued an emergency use authorization (EUA) for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. FDA has subsequently reissued this EUA with revisions. Most recently, FDA revised the EUA to limit authorization to the use of COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting. Given that the clinical evidence in patients with immunosuppressive disease or receiving immunosuppressive treatment remains limited, data from additional adequate and well-controlled randomized trials remain necessary for a definitive demonstration of COVID-19 convalescent plasma efficacy and to determine the optimal product attributes.

**Pathways for Use of Investigational Convalescent Plasma**

Because convalescent plasma for the treatment of COVID-19 has not yet been approved for use by FDA,  it is an investigational product.  As such, its administration must be under the EUA or an IND.  The emergency use of COVID-19 convalescent plasma is not authorized under the EUA unless it is consistent with, and does not exceed, the terms of the Letter of Authorization, including the Scope of Authorization and Conditions of Authorization.   Alternatively, investigational convalescent plasma may be administered under the traditional IND regulatory pathway, a single-patient IND for emergency use, or an intermediate-size population expanded access IND.

The following pathways are available for administering or studying the use of COVID-19 convalescent plasma:

1. Emergency Use Authorization

Health care providers intending to administer COVID-19 convalescent plasma under the EUA are not required to report its use to FDA. Providers should refer to the Fact Sheet for Health Care Providers for information on the intended use and known and potential risks and benefits of COVID-19 convalescent plasma. The Fact Sheetalso provides a description of the product, information on the dosage, administration and storage of COVID-19 convalescent plasma, use in specific populations, and instructions for communicating with recipients.

As described in the Fact Sheet, health care providers must maintain records and conduct a thorough investigation of adverse reactions after transfusion of COVID-19 convalescent plasma, and must report fatalities to FDA as required in 21 CFR 606.170.  Refer to FDA’s guidance entitled, “Notifying FDA of Fatalities Related to Blood Collection or Transfusion” for recommendations on reporting fatalities related to blood transfusion to FDA.

2. Clinical Trials

The EUA is not intended to replace clinical trials that are critically important for the definitive demonstration of safety and efficacy of investigational convalescent plasma.  Ongoing clinical trials of investigational convalescent plasma should not be amended based on the issuance of the EUA.  Health care providers are encouraged to enroll patients in those trials and complete clinical trials to fully answer the questions about the effectiveness of convalescent plasma for the treatment of COVID-19.

Investigators wishing to study the use of convalescent plasma in a clinical trial should submit requests to FDA for investigational use under the traditional IND regulatory pathway (21 CFR Part 312). The Center for Biologics Evaluation and Research (CBER) Office of Blood Research and Review (OBRR) is committed to engaging with sponsors and reviewing such requests expeditiously. During the COVID-19 pandemic, INDs may be submitted via email to CBERDCC_eMailSub@fda.hhs.gov.

3. Expanded Access

An IND application for expanded access is an alternative for use of investigational convalescent plasma for patients with serious or immediately life-threatening COVID-19 disease who are not eligible or who are unable to participate in randomized clinical trials (21 CFR 312.305).  During the COVID-19 pandemic, INDs for expanded access, that are not single patient INDs, may be submitted via email to CBERDCC_eMailSub@fda.hhs.gov.

Single Patient IND for Emergency Use
	Given the public health emergency that the COVID-19 pandemic presents, FDA is continuing to facilitate access to investigational convalescent plasma through the process of a physician requesting a single patient IND for an individual patient with serious or life-threatening COVID-19 under 21 CFR 312.310. This process allows the use of an investigational drug for the treatment of an individual patient by a licensed physician upon FDA authorization, if the applicable regulatory criteria are met. Note, in such cases, a licensed physician seeking to administer investigational convalescent plasma to an individual patient must request the IND (see 21 CFR 312.310(b)).

	Note: Given that the intended use of COVID-19 convalescent plasma under the EUA is for treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting, and COVID-19 convalescent plasma is not authorized for the treatment of COVID-19 in immunocompetent patients, FDA expects few requests for single patient INDs. FDA recommends that physicians seeking to use convalescent plasma for treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment should do so under the EUA and not under single patient INDs. Other options for the use of investigational convalescent plasma are listed above.

	To obtain a single patient emergency IND, the requesting physician may contact FDA by completing **Form FDA 3926** (https://www.fda.gov/media/98616/download) and submitting the form by email to CBER_eIND_Covid-19@FDA.HHS.gov. CBER requests that all forms be filled out electronically to facilitate rapid review.  Hand written forms are often hard to read and may delay the processing of the request.  For more detailed instructions see the Form FDA 3926 Instructions (https://www.fda.gov/media/98627/download).

	For requests when the provider is unable to complete and submit Form FDA 3926 due to extenuating circumstances, or in the case of a medical emergency during the hours of 8pm and 8am Eastern Time (ET), i.e., when authorization and issuance of an IND number is needed before 8 am ET the next morning, the provider should contact FDA’s Office of Emergency Operations at 1-866-300-4374 to be routed to the appropriate clinical review staff for assistance with submitting the request and issuance of an IND number.**Collection of Convalescent Plasma**

Registered or licensed blood establishments collecting authorized COVID-19 convalescent plasma under the EUA or investigational convalescent plasma under an IND should refer to the guidance for recommendations on donor eligibility and qualification, testing plasma for anti-SARS-CoV2 antibodies, and labeling.

**Recordkeeping**

A health care provider who is participating in an IND, including an expanded access IND or single patient IND for emergency use, must maintain records for the investigational convalescent plasma unit(s) administered to the COVID-19 patient (21 CFR 312.62). Such records should include the unique identification number(s) (e.g., the ISBT donation identification number(s) of the unit(s)).

                                                                                  Content current as of:
      01/10/2022
              
              
Health Topic(s)
			  Infectious Disease
			    			       			    			       CoronavirusInvestigational New Drug Applications (INDs) for CBER-Regulated  Products
 
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