Author: estoddert

FDA Draft Guidance: Patient Engagement in Design and Conduct of Medical Device Clinical Investigations

The U.S. Food and Drug Administration (FDA) issued the draft guidance on September 23, 2019 on Patient Engagement in Design and Conduct of Medical Device Clinical Investigations.   The U.S. Food and Drug Administration (FDA or the Agency) values the experience and perspectives of patients and their family caregivers. FDA believes that these individuals can and should […]

CDER SBIA Webinar Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS)

Nov. 1, 2019 1:00 p.m. Eastern FREE FDA is establishing a new submission process for investigational new drug (IND) safety reports. Submission of this important safety information as structured data will improve FDA’s ability to review and track safety signals that occur during the conduct of clinical trials. It will also provide sponsors with a […]

FDA Webinar: OPDP Electronic Submissions – Common Errors in eCTD and How to Avoid Them

October 25, 2019 1:00 PM – 2:00 PM (Eastern, UTC – 0400) Virtually Online Now that FDA accepts promotional submissions in eCTD format, the agency’s goal is to reduce the time required to process submissions and route files from the reviewer as quickly as possible. Topics for the webinar include: The most common types of […]

Webinar on PHUSE/FDA Data Science Innovation Challenge

October 8, 2019 10:00 a.m. – 11:00 am EDT PHUSE invites you to a special webinar announcing the “PHUSE/FDA Data Science Innovation Challenge”. The challenge provides a framework and an opportunity for the greatest minds in the data sciences arena to come together and collaborate intensively on projects during a defined time frame to create […]

Six New Modules added to CDER Learn

CDRH Learn is the FDA’s Center for Devices and Radiological Health (CDRH) web page for multimedia industry education and provides free learning modules describing many aspects of medical device and radiation-emitting product regulations, covering both premarket and postmarket topics. New modules were added on September 30, 2019: Start Here/The Basics! – (New modules 9/30/19)MDUFA Small Business […]

Real Life Film Series: The Bleeding Edge

October 15, 2019 from 12:10 PM to 1:00 PM Tompkins McCaw Library, Lecture Room 2-010 (509 N. 12th St., Richmond, Va. 23298) Students, faculty, staff and health professionals are invited to the screening of the engaging documentary, The Bleeding Edge. Look at the unforeseen consequences of advanced technological devices used in the medical field. Then join […]

FDA Medical Device Webinars for October 2019

The FDA’s Center for Devices and Radiological Health (CDRH) hosts webinars to help educate stakeholders on guidances and other topics related to the regulation of medical devices and radiation-emitting products. These forums provide the medical device industry and others with the chance to interact with FDA officials and have their questions answered. Webinars scheduled for […]

Recently Posted FDA Guidance Documents

9/27/2019 – Clinical Decision Support Software [DRAFT] The Food and Drug Administration (FDA) has long regulated software that meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including software that is intended to provide decision support for the diagnosis, treatment, prevention, cure, or mitigation of diseases […]

FDA Pharmaceutical Quality Symposium

Oct. 16-17, 2019 College Park, MD or Online Free and open to the public FDA will discuss the latest developments in pharmaceutical quality and provide case studies that illustrate the most effective ways to address quality issues and interact with the agency. In this era of globalization, engaging stakeholders is essential to furthering the overall […]

Sept. 19: Live Webcast – Privacy and Health Research in a Data-Driven World

Thursday, September 19, 2019, 8:15AM-4:15PM EDT This webcast is free of charge and no advance registration is required. You will be able to view the event at on 9/19. The U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) is hosting its 2nd Annual Exploratory Workshop on September 19, 2019. It will explore […]

Follow this blog