User uploaded custom header image

Tag: COVID-19

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: Guidance for Industry 8/17/2020 – Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Draft Guidance for […]

OMH Virtual Symposium on COVID-19

Free virtual symposium for Advancing the Response to COVID-19: Sharing Promising Programs and Practices for Racial and Ethnic Minority Communities  The U.S. Department of Health and Human Services (HHS) Office of Minority Health is hosting a virtual symposium on Sept.17 to highlight state, tribal, territorial, and community-based efforts to address COVID-19 among racial and ethnic minority populations. […]

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 […]

FDA Insight Podcast

Join Dr. Anand Shah, FDA’s Deputy Commissioner for Medical and Scientific Affairs, and other FDA leaders as they provide their insight into issues facing the agency – including the COVID-19 pandemic and other emerging topics. New episodes on Tuesdays! Ep. 1: Fighting COVID-19 at the FDA Ep 2: All About COVID-19 Testing Ep 3: Food […]

Webinar on FDA’s Regulation of Face Masks and Surgical Masks During the COVID-19 Pandemic

On Tuesday, August 4, 12:00 p.m.-1:00 p.m. ET, the U.S. Food and Drug Administration (FDA) will host a webinar on the FDA’s regulation of face masks and surgical masks during the COVID-19 pandemic. This webinar will expand the scope of the respirator webinar series to discuss face masks and surgical masks. During this webinar, representatives […]

Follow this blog