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The FDA is remaining vigilant in their monitoring of OTC hand sanitizer products. Their highest concerns, from a manufacturing and marketing perspective, are hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. They are also taking action against companies who are making an “FDA approved” claim since no hand sanitizers are approved by FDA. False or misleading, unproven claims are also high on their list of misbranding offenses that are being called out. The agency has also developed a webpage to alert the public on dangerous products that should not be used: FDA Updates on Hand Sanitizers with Methanol. Contact EAS if you have questions or concerns about your products or suppliers’ compliance with the regulations.

The FDA issued for immediate implementation, the updated draft guidance document Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking, which supersedes the guidance document issued on 5 November 2018. The guidance describes FDA’s intention with regard to enforcement of these requirements for class I and unclassified devices. According to the guidance, the FDA does not intend to enforce standard date formatting, UDI labeling, and GUDID data submission requirements for class I and unclassified devices, other than I/LS/LS devices, before 24 September 2022. Full details are available in the Guidance Document.

The FDA has announced, their preparation for resumption of domestic inspections. Scheduled to begin the week of 20 July 2020, the FDA will base their prioritized inspection schedule on data about COVID-19’s trajectory in a given state and locality, taking into consideration the rules and guidelines in place for each state and local government. For the foreseeable future, prioritized domestic inspections will be pre-announced to FDA-regulated businesses, for the safety and wellbeing of investigator’s and the firm’s employees.

Guidance Document updates on the FDA website:

CDER:

Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research

This guidance outlines FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. Cannabis and cannabis-derived compounds that may be used in drug manufacturing include botanical raw materials, extracts, and highly purified substances of botanical origin. This guidance does not address development of fully synthetic versions of substances that occur in cannabis, sometimes known as cannabis-related compounds, which are regulated like other fully synthetic drugs. This guidance is limited to the development of human drugs and does not cover other FDA-regulated products.

CDRH:

Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia

FDA has developed this draft guidance to propose select updates to the FDA guidance document “Guidance for the Non‐Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH).” The existing guidance on devices used for the treatment of BPH remains in effect, in its current form, until this draft guidance is finalized. FDA intends to incorporate this draft guidance into one final guidance document after obtaining and considering public comment on these select updates.

Clinical Investigations for Prostate Tissue Ablation Devices

This guidance document provides recommendations for (1) complying with the clinical testing special control under 21 CFR 876.4340(b)(8) for premarket notifications (510(k)s) for high-intensity ultrasound systems for prostate tissue ablation, and (2) collecting clinical data to support marketing submissions for new types of prostatic tissue ablation devices. High-intensity ultrasound systems for prostate tissue ablation transmit high-intensity therapeutic ultrasound energy into the prostate to thermally ablate a defined, targeted volume of tissue. Other prostate ablation devices achieve the same clinical effect of ablating targeted tissue volumes using different sources of energy. Regardless of the energy type used for ablation, these devices may receive marketing authorization for a general indication for ablation of prostatic tissue. This guidance does not address intended uses for the treatment of a specific disease (e.g., prostate cancer or benign prostatic hyperplasia).

Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)

FDA has developed this draft guidance to propose select updates to the FDA guidance document “Guidance for the Non‐Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH).” The existing guidance on devices used for the treatment of BPH remains in effect, in its current form, until this draft guidance is finalized. FDA intends to incorporate this draft guidance into one final guidance document after obtaining and considering public comment on these select updates.

Select Updates for Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions

FDA has developed this draft guidance to propose select updates to the FDA guidance document “Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions.” The existing guidance on peripheral vascular atherectomy devices remains in effect, in its current form, until this draft select update is finalized. FDA intends to incorporate this draft select update guidance with the existing guidance into one final guidance document after obtaining and considering public comment on these select updates.

CDER & CBER:

Development of Anti-Infective Drug Products for the Pediatric Population

The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products for the pediatric population.

Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry

This guidance provides information, as described in section 505-1(h) of the Federal Food, Drug, and Cosmetic Act, on what types of changes to REMS will be considered modifications of the REMS and what types of changes will be considered revisions of the REMS (changes that may be implemented following notification to the FDA).

Cancer Clinical Trial Eligibility Criteria: Brain Metastases

This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of patients with brain metastases. This guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of clinical trials.

Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients

This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of pediatric patients (i.e., children and adolescents) when appropriate. This guidance is intended to assist stakeholders, including sponsors and institutional review boards (IRBs), responsible for the development and oversight of clinical trials.

Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections

This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of patients with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infections. This guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of clinical trials.

Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies

This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of patients with organ dysfunction or with prior or concurrent malignancies. This guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of clinical trials.

CBER & CDRH:

Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use

We, FDA, are providing you, human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff, with our current thinking on the criteria under Title 21 of the Code of Federal Regulations (CFR) Part 1271, specifically the 21 CFR 1271.10(a)(1) criterion of minimal manipulation and the 21 CFR 1271.10(a)(2) criterion of homologous use.

This guidance supersedes the guidance of the same title dated November 2017 and corrected December 2017. This guidance revises section V. to extend the period of enforcement discretion through May 31, 2021.

Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act

This guidance describes how FDA interprets and plans to implement the requirements of section 745A(b)(3), while individual guidances will be developed to specify the formats for specific submissions and corresponding timetables for implementation. Specifically, this guidance discusses (1) the submission types that must be submitted electronically, (2) the timetable and process for implementing the requirements, and (3) criteria for waivers of and exemptions from the submissions in electronic format requirements.

Review and Update of Device Establishment Inspection Processes and Standards

FDA is issuing this guidance to comply with section 702(b)(1) of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which directs FDA to issue guidance that specifies how the Agency will implement uniform processes and standards that are applicable to inspections ( other than for-cause) of foreign and domestic medical device establishments. FDA updated processes and standards as needed, to address the new provisions in section 704(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that were added by FDARA section 702(a), and to establish a standard timeframe for inspections. This guidance also describes standardized methods of communication during the inspection process, and identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments.

CBER:

Development and Licensure of Vaccines to Prevent COVID-19

FDA is issuing this guidance to assist sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19.

CVM:

CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species

The Minor Use and Minor Species Animal Health Act of 2004 (commonly referred to as the “MUMS” Act) amended the FD&C Act to provide incentives to sponsors to develop “MUMS drugs,” that is, new animal drugs for use in minor species or for use in major species afflicted with uncommon diseases or conditions (minor uses), while ensuring appropriate safeguards for animal and human health.

This guidance is intended to assist those interested in pursuing FDA approval of these new animal drugs. It outlines the basic requirements and special considerations for approvals of MUMs drugs and describes the incentives available to encourage their development.

CVM GFI #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs

This guidance describes principles for designing, conducting, and reporting the results for investigations or studies, including data from foreign countries, in submissions to CVM to demonstrate substantial evidence of effectiveness for new animal drug applications or a reasonable expectation of effectiveness for applications for conditional approval of a new animal drug. It also describes how sponsors may obtain feedback from CVM regarding the incorporation of data from foreign countries into investigations and study protocols before the submission of an application.

CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs

This guidance describes how CVM intends to evaluate real-world data and real-world evidence in submissions to CVM to demonstrate substantial evidence of effectiveness for new animal drug applications or a reasonable expectation of effectiveness for applications for conditional approval of a new animal drug. It also provides information about how sponsors may obtain feedback from CVM on technical issues related to the use of real-world data and real-world evidence before the submission of an application.

CVM GFI #267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs

This guidance describes principles for designing, conducting, and reporting the results for investigations or studies including biomarkers and/or surrogate endpoints to demonstrate substantial evidence of effectiveness or a reasonable expectation of effectiveness of drugs intended for use in animals and to support the approval of a new animal drug application (NADA) or an application for conditional approval of a new animal drug (CNADA). This guidance also provides information about obtaining feedback from CVM with respect to incorporating biomarkers and/or surrogate endpoints in investigations and study protocols for new animal drugs.

CVM GFI #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs

This draft guidance describes principles for designing, conducting, and reporting the results for investigations or studies, including adaptive design features, when they are incorporated into clinical investigations submitted to CVM to demonstrate substantial evidence of effectiveness for new animal drug applications or a reasonable expectation of effectiveness for applications for conditional approval of a new animal drug. It also provides information about how sponsors may obtain feedback from CVM on technical issues related to the use of adaptive and innovative designs before the submission of an application.

Potentially of interest recently published FDA information:

Medical Device Webinars and Stakeholder Calls

CDER Patient-Focused Drug Development

FDA Proposes New Rule on Reporting Requirements

Building on Successes of the Generic Drug Program, FDA Sets the Stage for the Next Generic Drug User Fee Amendments (GDUFA) Reauthorization Process

Third Party Performance Metrics

FDA Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone

Federal Register Notices of note:

FR Vol 85, No 141 Medical Devices; Exemptions From Premarket Notification: Class II Devices

FR Vol 85, No 140 Independent Third-Party Assessment of Investigational New Drug Food and Drug Administration-Sponsor Communication Practices in Prescription Drug User Fee Act VI; Public Meeting; Request for Comments

GUIDANCE DOCUMENTS intended to remain in effect only for the duration of the public health emergency:

All Divisions:

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (Updated 2 July 2020)

FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants,1 maintaining compliance with good clinical practice (GCP), 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.

CDRH:

Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA is issuing this guidance to help facilitate the availability of devices for use in transporting certain clinical specimens, including transport media that can be used to transport certain clinical specimens for use with molecular Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) assays or antigen-detection diagnostic SARS-CoV-2 assays (hereinafter collectively referred to as SARS-CoV-2 assays) for the duration of the COVID-19 public health emergency.

COVID specific FDA webpages:

Personal Protective Equipment EUAs

Ventilators and Ventilator Accessories EUAs

Coronavirus (COVID-19) and Medical Devices

In Vitro Diagnostics EUAs

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 List of Drugs Used for Hospitalized Patients with COVID-19 as of 13 July 2020

Posted in Drug and Device Corner.