Division of Clinical Research

Office of the Vice President and Innovation

Category results for: Policies & Guidance

FDA Issues Draft Guidance with Select Updates for Biocompatibility of Certain Devices that Contact Intact Skin

The FDA has issued the draft guidance Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin. This document describes proposed recommendations to assist manufacturers in preparing the following premarket submissions for certain medical devices that come into direct contact or indirect contact with the human body: premarket approval applications (PMAs), humanitarian device exemption […]

NIH Guidance on Charging Personal Protective Equipment for Grants that Support Clinical Trials and Clinical Research

NIH has received many inquiries from recipients regarding their ability to direct charge personal protective equipment (PPE) costs to their clinical trials and clinical research awards. In this recent Guide Notice, NIH provides criteria for applicants/recipients on when it is appropriate to direct charge PPE costs. Note: This guidance applies to all applicants and recipients of […]

Recently Posted FDA Guidance Documents

9/25/2020 – 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: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff 9/25/2020 – Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation […]

Recently Posted FDA Guidance Document

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 Link: www.fda.gov/media/142143/download

Recently Posted Guidance Documents

9/3/2020 – Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis, and Impact on Dosing and Labeling 9/2/2020 – Control of Nitrosamine Impurities in Human Drugs: Guidance for Industry 9/2/2020 – Investigational COVID-19 Convalescent Plasma: Guidance for Industry 8/31/2020 – Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: […]

FDA Issues Revised Draft Guidance, “Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing”

(9/3/2020): The U.S. Food and Drug Administration (FDA) issued a draft guidance for industry entitled, “Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing.” This revised draft guidance assists sponsors in the design and analysis of studies that assess the influence of impaired renal function on the pharmacokinetics and/or pharmacodynamics […]

Recently Posted FDA Guidance Documents

8/19/2020 – Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers: Guidance for Industry 8/18/2020 – Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) : Guidance for Industry 8/17/2020 – Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Draft Guidance for […]

New Subpart C Certification Submission Form

The Office for Human Research Protections (OHRP) would like to highlight the new Subpart C Certification Submission Form recently posted on the OHRP website. This form is intended to standardize the information submitted by institutions and reduce administrative delays caused by insufficient submissions. Institutions should submit the completed form as part of a Subpart C […]

New FDA Guidance for Cancer Clinical Trial Eligibility Criteria

New FDA guidances provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by CDER and CBER for the treatment of cancer. They include the following: 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 […]

FDA Finalizes Patient-Focused Drug Development Guidance – Drug Information Update

The U.S. Food and Drug Administration is announcing the availability of a guidance for industry, FDA staff, and other stakeholders entitled “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input .” This guidance finalizes the draft guidance of the same name issued on June 13, 2018. This guidance (Guidance 1) is the first of a series of four […]

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