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Guidance Document updates on the FDA website:

All Divisions:

Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic

This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic.

FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent of these possible changes is unknown. This guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic.

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

CDER:

FY 2021 PDUFA Dear Colleague Letter

Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency (Revised)

FDA is issuing this guidance to communicate its temporary policy for the compounding of certain human drug products for hospitalized patients by outsourcing facilities that have registered with FDA under section 503B of the Federal Food, Drug, and Cosmetic Act.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)). As noted below, the drugs that are the subject of this policy may change during the emergency.

Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency (Revised)

FDA is issuing this guidance to communicate its temporary policy for the compounding of certain human drug products for hospitalized patients by State-licensed pharmacies and Federal facilities, including hospital and health system pharmacies, that are not registered with FDA as outsourcing facilities for the duration of the public health emergency declared by the Secretary of Health and Human Services on January 31, 2020, or for such shorter time as FDA may announce through updated guidance.

This policy is intended to remain in effect for no longer than the duration of the public health emergency related to COVID-19 declared by HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)). FDA is continually assessing the needs and circumstances that make issuance of this guidance appropriate. As relevant needs and circumstances evolve, FDA intends to update, modify, or withdraw policies in this guidance as appropriate.

Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency

Due to the COVID-19 pandemic, FDA has received a number of queries from compounders related to the impact of supply interruptions of face masks, gowns, gloves, and other garb, which we refer to collectively in this document as personal protective equipment (PPE).

FDA is issuing this guidance to communicate its temporary policy related to PPE use during human drug compounding, at State-licensed pharmacies or Federal facilities that are not registered with FDA as outsourcing facilities.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the U.S. Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(A)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)).

CDER & CBER:

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

FDA is issuing this guidance to assist sponsors in the clinical development of drugs for the treatment or prevention of COVID-19. Preventative vaccines and convalescent plasma are not within the scope of this guidance.

This guidance is intended to remain in effect for the duration of the public health emergency related to COVD-19 declared by the Department of Health and Human Services, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service (PHS) Act. However, the recommendations described in the guidance are expected to assist the Agency more broadly in its continued efforts to assist sponsors in the clinical development of drugs for the treatment of COVID-19 beyond the termination of the COVID-19 public health emergency and reflect the Agency’s current thinking on this issue.

Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency

Due to the COVID-19 pandemic, FDA has been monitoring requests related to provisions of the Drug Supply Chain Security Act (DSCSA) because the provisions may affect the prescription drug supply chain during the COVID-19 outbreak.

FDA is issuing this guidance to clarify the scope of the public health emergency exemption and exclusion under the DSCSA for the duration of the public health emergency declared by the Secretary of Health and Human Services on January 31, 2020, effective January 27, 2020, and renewed for 90 days on April 21, 2020, effective April 26, 2020, to help ensure adequate distribution of finished prescription drug products throughout the supply chain to combat COVID-19.

In addition, this guidance announces FDA’s policy regarding the exercise of its discretion in the enforcement of authorized trading partner requirements under section 582(b)(3), (c)(3), (d)(3), and (e)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for certain distributions during the COVID-19 public health emergency involving other trading partners that may not be authorized trading partners.

COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products

FDA is issuing this guidance to provide general considerations to assist sponsors in preparing pre-investigational new drug application (pre- IND) meeting requests for COVID-19 related drugs1 for the duration of the COVID-19 public health emergency. As described in further detail in this guidance, FDA recommends that sponsors initiate all drug development interactions for COVID-19 related drugs through IND meeting requests.

This guidance is intended to provide sponsors with an initial framework to help organize their pre-IND meeting requests during the COVID-19 public health emergency. This document is intended to complement other guidance documents providing recommendations regarding drug development programs for COVID-19, including the guidance for industry COVID-19: Developing Drugs and Biological Products for Treatment or Prevention(May 2020).

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2))

CDRH:

Classification of Posterior Cervical Screw Systems: Small Entity Compliance guide

On April 1, 2019, FDA published a final rule in the Federal Register entitled “Classification of Posterior Cervical Screw Systems”. This final rule created the classification regulation 21 CFR 888.3075 for posterior cervical screw systems and established special controls. FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act to assist small entities to comply with the requirements established in 21 CFR 888.3075.

Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA is issuing this guidance to provide a policy to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides (“digital pathology slides”) (hereinafter these devices will be referred to as “remote digital pathology devices”) during this pandemic.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)).

Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)

FDA is issuing this guidance to provide a policy to help accelerate the availability of novel coronavirus (COVID-19) tests developed by laboratories and commercial manufacturers for the duration of the public health emergency. This guidance describes a policy for laboratories and commercial manufacturers to help accelerate the use of tests they develop in order to achieve more rapid and widespread testing capacity in the United States.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act).

Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency

FDA is issuing this guidance to provide a policy to help expand the availability of surgical apparel for health care professionals, including gowns (togas), hoods, and surgeon’s and patient examination gloves during this pandemic.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Services (PHS) Act.

Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency

FDA is issuing this guidance to implement section 506J of the Federal Food, Drug, and Cosmetic Act, as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act, as it relates to device shortages and potential device shortages occurring during the COVID-19 pandemic, for the duration of the COVID-19 public health emergency. Section 506J of the FD&C Act requires manufacturers to notify FDA of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States.

This guidance is intended to assist manufacturers in providing FDA timely, informative notifications about changes in the production of certain medical device products that will help the Agency prevent or mitigate shortages of such devices during the COVID-19 public health emergency. This guidance also recommends that manufacturers voluntarily provide additional details to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

CDRH & CBER:

eCopy Program for Medical Device Submissions

This is an updated version of the guidance that was issued on October 10, 2013. It provides clarification to the processing and technical standards for eCopies based on FDA’s experience to date with the program. The purpose of this guidance is to explain the new electronic copy (eCopy) Program for medical device submissions.

Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA is issuing this guidance to provide a policy to help address current manufacturing limitations or supply chain issues due to disruptions caused by the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of HHS on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

CBER:

Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma

This guidance recognizes the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 2.1 dated May 2020, prepared by the Plasma Protein Therapeutics Association (PPTA). This guidance also advises Source Plasma manufacturers on how to report implementation of the acceptable PPTA Source Plasma donor history questionnaires and accompanying materials (SPDHQ documents) under Title 21 of the Code of Federal Regulations 601.12 (21 CFR 601.12).

Investigational COVID-19 Convalescent Plasma

FDA is issuing this guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. The guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma.

CVM:

CVM Broadcast 44:

Background

CVM decided to close the DCU until further notice for safety reasons. This change will impact ESS registration submissions sent to CVM at the following location:

  • 7500 Standish Place (MPN2)

Closing the DCU will affect the following functions:

  • No new mail will be received at 7500 (MPN2) and will instead be held at the Wilkens Avenue facility.
  • No paper letters will be issued in response to submissions.

CVM will provide a follow-up broadcast message when DCU service resumes.

If you have any questions or concerns, please email CVMDCU@fda.hhs.gov

CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency

FDA has been closely monitoring the animal drug supply chain for supply disruptions or shortages in the United States during the COVID-19 pandemic. FDA is issuing this guidance to assist sponsors in providing FDA timely, informative notifications about changes in the production of animal drugs that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of these products.

Federal Register Notices of note:

FR Vol 85, No. 90

Notice of Follow-up to Notice of Public Hearing and Request for Comments on Devices Proposed for a New Use With an Approved, Marketed Drug

FR Vol 85, No. 92

Guidance Documents Related to COVID-19; Availability

COVID webpages that may be of interest:

Posted in Drug and Device Corner.