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Sep 17, 2020

 
Recognition and Withdrawal of Voluntary Consensus Standards
On 14 September 2020 the FDA announced the availability of the final guidance for industry and FDA staff.

The FDA developed this document to provide guidance to industry and FDA staff about the procedures the Center for Devices and Radiological Health (CDRH) follows when we receive a request for recognition of a voluntary consensus standard for medical products. The guidance outlines principles for recognizing a standard wholly, partly, or not at all, as well as reasons and rationales for withdrawing a standard.

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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
On 14 September 2020 the FDA announced the availability of the guidance for industry.

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. This guidance is not intended for development programs evaluating products to treat or prevent post-infectious COVID-19 conditions such as multisystem inflammatory syndrome in children or to development programs for preventative vaccines. This guidance does not address considerations for clinical trial design other than those pertaining to the measurement and analysis of COVID-19-related symptoms among outpatients.

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Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency
On 10 September 2020 the FDA announced the availability of the guidance for industry.

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. This guidance describes how to evaluate and prioritize the remediation of CGMP activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply.

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Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process"
On 4 September 2020 the FDA announced the availability of the final guidance for industry and FDA staff.

FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), 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. The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" to support applications to FDA. This guidance replaces Office of Device Evaluation (ODE) Blue Book Memorandum #G95-1 (1995), entitled "Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.’" This guidance document also incorporates several new considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials, which were not previously discussed in G95-1.

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Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling
On 3 September 2020 the FDA announced the availability of the draft final guidance for industry.

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. It provides recommendations on when studies should be conducted to assess the influence of renal impairment on the pharmacokinetics of an investigational drug, the design of such studies, and how such studies should be carried out.

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MHRA Post-Transition Period Information
On 1 September 2020 the UK MHRA published guidance for industry and organizations to follow from 1 January 2021.

From 1 January 2021, the MHRA will be the UK’s standalone medicines and medical devices regulator. Stakeholders need to get ready for new rules from 1 January 2021.

The MHRA has issued a series of guidance, effective from 01 January 2021, including guidance on registration of clinical trials for investigational medicinal products and publication of summary results, substantial amendments to a clinical trial, regulating medical devices, licensing, importing and exporting, IT systems, pharmacovigilance, pediatric studies.

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