Author: komornikea

FDA Guidance “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency”

On January 15, 2021, FDA published a new guidance for industry, Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency. FDA is issuing this guidance to assist prospective applicants of abbreviated new drug applications (ANDAs) in ensuring the protection of participants when resuming or initiating bioequivalence (BE) studies conducted […]

National Organization for Arts in Health Now Open to Non-Members

Creative Response Forum: Healthcare Provider Burnout Part 2 Time: 10am PST / 11am MST / 12pm CST / 1pm EST How are you using the arts to address healthcare provider burnout?  Additional shares: Evaluation: how do you learn its impact? Metrics: how many HCPs are engaging, how frequently and for how long (and how do you know)? How can […]

FDA Virtual Public Meeting on Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials

The Food and Drug Administration announceded a virtual public meeting titled “Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials.” The meeting will be convened on February 2nd and 3rd by Duke University’s Robert J. Margolis, MD, Center for Health Policy, and supported by a cooperative agreement with FDA. The meeting […]

FDA Virtual Workshop – February 16-17, 2021

FDA Virtual Workshop: Evaluating RWE from Observational Studies in Regulatory Decision-Making  The U.S. Food and Drug Administration and the Duke-Margolis Center for Health Policy will hold a two-day virtual workshop on February 16-17, 2021, focused on considerations about observational (non-interventional) study design and conduct when using evidence from observational studies to inform regulatory decisions.     FDA defines real-world evidence (RWE) as the clinical evidence regarding a medical product’s […]

FDA Posted Guidance Documents

New FDA Posted Guidance Documents 1/6/2021 – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Guidance for Industry and Food and Drug Administration Staff 1/6/2021 – Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration Staff 1/5/2021 – Mouse Embryo Assay for Assisted Reproduction Technology Devices 1/5/2021 – Human Gene […]

FREE Health and Humanities Conference

Date/Time: Saturday, January 23, 2021; 1:00 – 4:30 PM EST Location: Virtual Cost: Free The Jacalyn Duffin Health and Humanities Conference aims to create a space where learners and educators of all disciplines can discuss the intersections of health, medicine, and the arts and humanities. This year’s conference theme is “Sensations and The Sensational.” Health, disease, wellness, […]

The FDA issues Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan

On 01/12/2021, the U.S. Food and Drug Administration (FDA) issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” from the Center for Devices and Radiological Health’s Digital Health Center of Excellence. The Action Plan is a direct response to stakeholder feedback to the April 2019 discussion paper, “Proposed Regulatory Framework […]

Healing/Arts Workshop with Steven T. Licardi

Date: Thursday, January 14 at 4 pm  Register here: https://forms.gle/wyRc7ewMemq77HAy8 Healing/Arts is a virtual event series focused on the intersections between the arts, health, and activism.  Steven T. Licardi will lead a presentation and writing workshop exploring the use of erasure poetry to rewrite mental health narratives, to redefine mental illness, and to excavate our own relationship […]

CDER Compliance Conference

January 14, 2021 | 9:00 a.m. – 3:30 p.m. Eastern This conference is FREE and has been approved for 4.25 continuing education units for physicians, pharmacists, and nurses. See CE announcement for more details. Click here to register: https://www.fda.gov/drugs/news-events-human-drugs/cder-compliance-conference-01142021-01142021?utm_medium=email&utm_source=govdelivery In SBIA’s first conference dedicated to compliance, participants will learn from FDA subject matter experts on a range of drug compliance topics […]

NIMHD Envisioning Health Equity Art Challenge 2020

NIMHD Envisioning Health Equity Art Challenge 2020 Art Challenge logo The National Institute on Minority Health and Health Disparities (NIMHD) is celebrating its 10-year anniversary as an Institute at the National Institutes of Health! As part of our celebration, we are hosting an art competition inviting individuals to submit images (paintings, drawings, photos, digital art, […]

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