Tag: COVID-19

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 […]

Guidance for Clinical Research Teams as COVID-19 Cases Rise

Due to significant increases in COVID-19 cases at VCU Health and throughout our community, we are sharing additional guidance essential for the safe conduct of clinical research during unpresedented challenges to our healthcare infrastructure: Actively support the safety and wellbeing of your research participants given the rapidly evolving conditions of the pandemic. Evaluate the potential for added […]

VCU Health system COVID-19 information – clinical research team members

In response to the Virginia Occupational Safety and Health (VOSH) Program and Virginia Department of Labor and Industry (DOLI) Emergency Temporary Standard related to COVID-19, VCUHS is providing education on PPE requirements and risks associated with COVID-19 transmission on the VCU Health COVID19 Intranet Site. Please complete the following RedCap survey if possible. Link:   https://redcap.vcu.edu/surveys/?s=E4RPFDNN3F

FDA virtual Town Hall for test developers on SARS-CoV-2

Oct. 7 from 12:15 – 1:15 p.m. On Wednesday, October 7, 2020, from 12:15 pm – 1:15 pm Eastern Time, the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for test developers for SARS-CoV-2. During this Town Hall, the FDA will answer technical questions about the development and validation of tests […]

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

HHS Office of Minority Health Hosts Virtual Symposium on COVID-19

Advancing the Response to COVID-19:Sharing Promising Programs and Practices for Racial and Ethnic Minority CommunitiesA Virtual Symposium Hosted by the HHS Office of Minority Health September 17, 2020 from 12:00 PM to 6:00 PM ET The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) is hosting a virtual symposium on Thursday, September […]

FDA Virtual Town Hall for Labs and Manufacturers on Coronavirus (COVID-19) Diagnostic Tests

On Wednesday, September 2, 2020, from 12:15 pm – 1:15 pm Eastern Time, the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2. During this Town Hall, the FDA will answer technical questions about the development […]

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 […]

SOCRA Update: At Home CCRP Testing

SOCRA recognizes the difficult nature that COVID-19 has placed on members. Balancing work, home, and professional development has put a tremendous stress on clinical research professionals. In an effort to support membership and the clinical research community during these extraordinary times, SOCRA has implemented Home Proctoring to allow individuals to sit for the CCRP® exam remotely.  Home Proctoring […]

OMH Virtual Symposium on COVID-19

Registration is now open for Advancing the Response to COVID-19: Sharing Promising Programs and Practices for Racial and Ethnic Minority Communities, a virtual symposium hosted by the U.S Department of Health and Human Services (HHS) Office of Minority Health (OMH) taking place on September 17, 2020. Join us to learn from national, state, tribal and local experts […]

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