Knowledge Center
Useful FDA educational resources
CDRH Learn
FDA’s Center for Devices and Radiological Health (CDRH) web page for multimedia industry education
https://www.fda.gov/training-and-continuing-education/cdrh-learn
CDRH Medical Device Webinars and Stakeholder Calls
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/medical-device-webinars-an
CDER Learn
The web page for educational tutorials offered by the Center for Drug Evaluation and Research
https://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education
CDER Meetings, Conferences, & Workshops
https://www.fda.gov/drugs/news-events-human-drugs/meetings-conferences-workshops-drugs
CBER Sponsored Workshops, Meetings & Conferences
https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/workshops-meetings-conferences-bi
OTAT Learn
The Center for Biologics, Evaluation and Research's (CBER) Office of Cellular, Tissue and Gene Therapies (OCTGT) web page for industry education.
https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/otat-learn
The Robert J. Margolis, M.D. Center for Health Policy
Calendar of Events
FDA CDER Small Business & Industry Assistance (SBIA)
https://www.fda.gov/drugs/development-approval-process-drugs/cder-small-business-industry-assistance
FDA Workshops & Conferences (Medical Devices)
https://www.fda.gov/medical-devices/news-events-medical-devices/workshops-conferences-medical-device
Additional Topics of Interest
All New England Journal of Medicine Content Related to the Covid-19 Pandemic - Freely Available
Visit New England Journal of Medicine Free Covid-19 Content
The COVID-19 Lit Rep
The COVID-19 Lit Rep is currently prepared by the UW Alliance for Pandemic Preparedness and the START Center in collaboration with and on behalf of the Washington State Department of Health. The Lit Rep was originally developed and disseminated by the WA DOH COVID-19 Incident Management Team to support evidence-based decision making throughout the region.
Click here to subscribe.
WIRB-Copernicus Group® (WCG) Free Webinars
Visit WCG's clinical page under webinars sections on the right for upcoming webinar registrations and past webinars available on demand.
The FDA and Prescription Drugs: Current Controversies in Context
Understand how the FDA regulates pharmaceuticals and explore debates on prescription drug costs, marketing and testing.
New Device Advice e-Learning Tool
The Medical Devices Bureau has announced the launch of a new Device Advice: e-Learning tool “Understanding How Medical Devices are Regulated in Canada – Premarket Regulations”. This learning module is intended to help stakeholders better understand what the premarket regulatory requirements are for the importation or sale of medical devices in Canada.
LifeScience Washington Programs
Click here for more info on LifeScience Washington programs and events
Tech Tip Videos
Cell Signaling Technology videos
New Medical Device Regulatory Intelligence Service from Emergo
The Regulatory Affairs Management Suite (RAMS) digital platform for global market access enables manufacturers to manage their device registrations and certifications across multiple countries and gain valuable market insights from a single, fully automated system. The software includes new tools and capabilities to support streamlined RA/QA operations.
Key capabilities include:
- Registration Tracker and Regulatory Updates
- Regulatory Overview Reports for 22 Markets
- All of Emergo’s Regulatory Process Charts
- Copies of global regulations already in Emergo’s website, plus expanded list of regulations and added markets
- FDA 510(k) review time calculator and classification support, which extracts real-time information through connection with the FDA’s website
- Regulatory FAQs to answer common and not so common questions and issues
Note: To Activate all features, make sure to enable them after signup by visiting the RAMS Marketplace. For questions, contact bdwest@ul.com