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On 1 April 2020, FDA Requests Removal of All Ranitidine Products from the Market immediately, for both prescription and OTC drugs. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications. Letters have been sent to all manufacturers by the agency.

FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation. Specifically of note is the portion of the bill that reforms and modernizes the way certain over-the-counter (OTC) drugs are regulated in the United States, a step that will have an impact lasting long after the current public health emergency. The law grants the FDA new authorities to modernize the OTC drug development and review process to help advance innovative, safe and effective options for consumers and secure a robust OTC marketplace. As the agency implements this important new law, updates will be published.

Guidance Document updates on the FDA website:

All Divisions:

Compliance Policy Guide Section 110.800 Post Detention Sampling Guidance for Industry

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

This guidance is being issued to address the COVID-19 public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration has determined that prior public participation for this guidance is not feasible or appropriate. This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

Comments may be submitted at any time for Agency consideration. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. All comments should be identified with the docket number FDA-2020-D-1106 and complete title of the guidance in the request.

Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products

This guidance describes considerations for the development and labeling of in vitro companion diagnostic devices to support the indicated uses of multiple drug or biological oncology products, when appropriate. This guidance builds upon existing policy regarding the labeling of companion diagnostics. In a prior guidance issued in 2014, the Agency stated that if evidence is sufficient to conclude that the companion diagnostic is appropriate for use with a specific group of therapeutic products, the companion diagnostic’s intended use/indications for use should name the specific group of therapeutic products, rather than specific products.

Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA

This guidance covers emergency-use injectors submitted under a biologics license application (BLA), new drug application (NDA), or abbreviated new drug application (ANDA). The term “emergency-use injector” means injectors marketed with an emergency-use drug as a prefilled single entity combination product under 21 CFR 3.2(e)(1) or as a co-packaged combination product under 21 CFR 3.2(e)(2). Emergency-use injector includes pen injectors, autoinjectors, or on-body-wearable delivery systems for drugs for emergency treatment of conditions such as anaphylaxis, opioid overdose, poisoning, or severe hypoglycemia.

CDER & CBER:

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD & C Act

FDA is issuing this guidance, in light of the COVID-19 pandemic, to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain drugs and biological products that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of such products.

CDRH:

Center for Devices and Radiological Health (CDRH) Appeals Processes: Q & A About 517A

This guidance document provides the Center for Devices and Radiological Health interpretation of key provisions set forth in section 517A of the Federal Food, Drug, and Cosmetic Act, as those provisions pertain to requests for appeals of significant decisions under 21 CFR 10.75, as well as for the timeframes and procedures of regulatory decisions and actions taken by CDRH under 21 CFR 800.75.

CDRH & CBER:

Nonbinding Feedback After Certain FDA Inspections of Device Establishments

FDA is issuing this guidance document to comply with section 702 of the FDA Reauthorization Act of 2017. The purpose of this guidance is to explain how the owner, operator, or agent in charge of a device establishment may submit a request for nonbinding feedback to FDA regarding actions the firm has proposed to take to address certain kinds of inspectional observations that have been documented on an FDA Inspectional Observations Form (Form FDA 483) and issued to the firm upon completion of an inspection of the firm’s establishment. This guidance identifies a standardized method for communicating and submitting requests for nonbinding feedback and describes how FDA evaluates and responds to such requests.

CBER:

Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components

The FDA is issuing this guidance document to provide, blood establishments that collect blood and blood components, with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease by blood and blood components. The recommendations in this guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma.

Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

This revised guidance document provides blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. The FDA also recommends that establishments make corresponding revisions to their donor educational materials, donor history questionnaires and accompanying materials, along with revisions to donor requalification and product management procedures.

Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria

This revised guidance document provides blood establishments that collect blood and blood components, with FDA’s recommendations to reduce the risk of transfusion-transmitted malaria (TTM). The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma.

CVM:

CVM GFI #259 (VICH GL58) Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV

This document is an annex to the VICH parent stability guidance, CVM Guidance for Industry (GFI) #73/VICH GL3(R), “Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)” and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration or application submitted within the regions in climatic zones III and IV.

Federal Register Notices of note:

Federal Register Vol 85, No. 63 – Emergency Use Authorization Declaration

Federal Register Vol 85, No. 64 – Medical Devices; Technical Amendments. These revisions are solely to reflect changes to organization structure and addresses. The rule does not impose any new regulatory requirements on affected parties. Additionally, the agency is amending certain medical device regulations to accurately reflect the devices exempted from premarket notification (510(k)).

COVID specific updates:

CDER:

Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency

FDA is issuing this guidance to communicate its policy for the temporary use of certain gas containers for oxygen and nitrogen intended for medical use for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

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

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 (FD&C Act) (21 U.S.C. 353b).

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 Guidance for Industry

This guidance is being issued to address the COVID-19 public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration has determined that prior public participation for this guidance is not feasible or appropriate. This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency

This guidance is being issued to address the COVID-19 public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration has determined that prior public participation for this guidance is not feasible or. This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA is issuing this guidance to provide a policy to help expand the availability and capability of medical x-ray, ultrasound, and magnetic resonance imaging systems, and image analysis software that are used to diagnose and monitor medical conditions while mitigating circumstances that could lead to patient, healthcare provider, and healthcare technology management (HTM) exposure to COVID-19 for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, and renewed for 90 days on April 21, 2020, effective April 26, 2020.

CBER:

Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency

FDA is issuing this guidance to provide a notice of exceptions and alternatives to certain requirements in Title 21 of the Code of Federal Regulations (CFR) regarding blood and blood components. This notice of exception or alternatives to certain requirements is being issued under 21 CFR 640.120(b) to respond to a national public health need and address the urgent and immediate need for blood and blood components.

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.

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

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

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 (referred to collectively in this guidance as compounders).

Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA is issuing this guidance to provide a policy to help expand the availability and capability of sterilizers, disinfectant devices, and air purifiers during this public health emergency.

Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)

FDA is issuing this guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals during this pandemic.

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.

Enforcement Policy for Clinical Electronic Thermometers 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 clinical electronic thermometers to address this public health emergency.

Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA is issuing this guidance to provide a policy to help expand the availability and remote capabilities of infusion pumps and their accessories for health care professionals during the COVID-19 pandemic.

Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA is issuing this guidance to provide a policy to help expand the capability of remote ophthalmic assessment and monitoring devices to facilitate patient care while reducing patient and healthcare provider contact and exposure to COVID-19 during this pandemic.

Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders 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 digital health therapeutic devices for psychiatric disorders to facilitate consumer and patient use while reducing user and healthcare provider contact and potential exposure to COVID-19 during this pandemic.

Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass 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 used in extracorporeal membrane oxygenation (ECMO) therapy to address this public health emergency.

Enforcement Policy for Telethermographic Systems 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 telethermographic systems used for body temperature measurements for triage use for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA is issuing this guidance to provide a policy to help expand the availability and capability of non-invasive fetal and maternal monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and potential exposure to COVID-19 during this pandemic.

Further COVID webpages that may be of interest:

FDA March 24, 2020 Communication re EUA issued for ventilators

FAQs on Ventilators

Coronavirus Treatment Acceleration Program (CTAP)

Emergency Use Authorizations (Medical Devices)

FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic

Coronavirus (COVID-19) – Drugs

Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19

FAQs on Diagnostic Testing for SARS-CoV-2

Posted in Dietary Supplements, Drug and Device Corner, Drugs, Medical Devices.