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EAS would like to remind all eNews readers of the importance of an appointed U.S. Agent. The FDA recently deactivated the FDA registrations of 340 foreign establishments that failed to identify a U.S. Agent as required by FDA’s regulations. As we head into the FDA registration renewal period, please make sure EAS has accurate and up to date contact information for your company / facility.

As previously touched upon, the FDA medical device facility registration renewal, drug establishment registration renewal and drug listing certification period begins 1 October 2020. EAS will be reaching out to confirm clients’ wish for us to perform these processes. Please feel free to contact Victoria Pankovich at vpankovich@easconsultinggroup.com proactively if you would like.

With the holiday season about to kick into high gear, it is a good time to remember FDA’s guidance regarding packaging and marketing of hand sanitizers in food or drink type packages, or hand sanitizers with scents that are food flavors. These type of marketing efforts lend to significant confusion on consumers part and present a risk of potential inadvertent use. The agency has received reports of ingestion of such products. The FDA continues to monitor hand sanitizers and will take appropriate action, as necessary.

The eMDR system will be updated to include fields from the newest version of the FDA Form 3500A. In preparation for these updates to the eMDR system, the FDA expects AS2 submitters to make the corresponding updates to their systems to provide higher-quality information about adverse events. Refer to the eMDR Implementation Package for a complete list of changes.

The FDA recently announced a required label change to include a boxed warning for benzodiazepines indicating a risk of abuse, addiction and other serious risks.

FDA has published their newly added and newly revised Product-Specific Guidances for Generic Drug Development.

All divisions

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 (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency.

CDER

Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry

The purpose of this guidance is to assist sponsors in the clinical development of drugs and therapeutic biologics for the treatment of eosinophilic esophagitis (EoE).

Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling

This guidance is intended to assist sponsors planning to conduct studies to assess the influence of renal impairment on the pharmacokinetics of an investigational drug

Control of Nitrosamine Impurities in Human Drugs

This guidance recommends steps manufacturers of APIs and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products. The guidance also describes conditions that may introduce nitrosamine impurities.

CDER & CBER

Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry

This guidance is intended to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of geriatric information in labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products.

Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment

FDA is issuing this guidance to provide sponsors and investigators with considerations for approaches on how common COVID-19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in outpatient adult and adolescent subjects.

Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency

FDA is issuing this guidance to help drug and biological product manufacturers during the COVID-19 public health emergency plan and prioritize current good manufacturing practice (CGMP) activities as they transition from operations impacted by the public health emergency to normal manufacturing operations.

Evaluating Cancer Drugs in Patients with Central Nervous System Metastases

The purpose of this guidance is to describe FDA’s recommendations for clinical trial designs of cancer drugs or biological products regulated by CDER and CBER that are intended to support product labeling describing the antitumor activity in patients with central nervous system (CNS) metastases from solid tumors originating outside the CNS.

Evaluating Cancer Drugs in Patients with Central Nervous System Metastases

The purpose of this guidance is to describe FDA’s recommendations for clinical trial designs of cancer drugs or biological products regulated by CDER and CBER that are intended to support product labeling describing the antitumor activity in patients with central nervous system (CNS) metastases from solid tumors originating outside the CNS.

CDRH & CBER

Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

This guidance provides information regarding how the basic safety and essential performance standards are incorporated into the Pilot Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the ASCA Pilot).

Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

This guidance provides information on how the Biological Evaluation of Medical Devices standards are incorporated into the Pilot Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the ASCA Pilot).

The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program

This guidance refers to voluntary consensus standards. For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database.

Recognition and Withdrawal of Voluntary Consensus Standards

The guidance outlines principles for recognizing a standard wholly, partly, or not at all, as well as reasons and rationales for withdrawing a standard.

Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”

FDA has developed this guidance document to assist industry in preparing Premarket Applications, Humanitarian Device Exceptions, Investigational Device Applications, Premarket Notifications, and De Novo requests for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body.

Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation

The objectives of this guidance are to: 1)Describe principles that may be considered when using PRO instruments in the evaluation of medical devices (Section III); 2) Provide recommendations about the importance of ensuring the PRO instruments are fit-for-purpose (Section III), and; 3) Outline best practices to help ensure relevant, reliable, and sufficiently robust PRO instruments are developed, modified, or adapted using the least burdensome approach (Section IV).

CBER

Investigational COVID-19 Convalescent Plasma

FDA is issuing this guidance to provide recommendations to health care providers and investigators on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the public health emergency. The guidance also provides recommendations to blood establishments on collection. We also describe FDA’s interim compliance and enforcement policy regarding the IND requirements for the use of investigational convalescent plasma. This document supersedes the guidance of the same title issued in April 2020 and updated in May 2020.

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

This revised guidance document provides you, 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.

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

We, FDA, are issuing this guidance document to provide you, blood establishments that collect blood and blood components, with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components.

CVM

CVM GFI #191 Changes to Approved NADAs – New NADAs vs. Category II Supplemental NADAs

This guidance is intended to assist sponsors who wish to apply for approval of changes to approved new animal drugs that require FDA to reevaluate safety and/or effectiveness data.

Federal Register publications of note

FR Vol 85, No 185 Regulations regarding “Intended Uses”

FR Vol 85 No. 169 Principles for Selecting, Developing, Modifying, and Adapting Patient-

Reported Outcome Instruments for Use in Medical Device Evaluation; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders;

COVID specific FDA webpages

Personal Protective Equipment EUAs

Webinar Series – Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic

Hand Sanitizers / COVID-19 webpage update

FDA updates on hand sanitizers consumers should not use

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