CDER Small Business & Industry Assistance (SBIA) | FDA

Register for Upcoming EventsDateTimeEventLocation Sub-Topic Paragraphs Regulatory References Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more SBIA Learn Online Training Repository Search for conferences, webinars, online courses, newsletters and podcasts SBIA on LinkedIn Stay connected and receive regulatory updates and event notifications SBIA Learning Library on YouTube Browse conference and webinar recordings on YouTube Guidances Related to Drugs Documents representing FDA's thinking on a particular subject Drug Approvals and Databases Approvals and medications – Drugs@FDA, FDALabel, Orange Book, and more Development & Approval Process Drug applications, submissions, manufacturing, and small business help Advisory Committees Independent opinions and recommendations from outside experts on applications to market new drugs and on FDA policies Paragraph Header Contact SBIA Contact Point CDER Small Business and Industry Assistance Division of Drug Information Office of Communications 10001 New Hampshire Ave Hillandale Building, 4th Fl Silver Spring, MD 20993 CDERSBIA@fda.hhs.gov (301) 796-6707 (866) 405-5367 Hours Available Center for Drug Evaluation and Research (CDER) For Latest Updates Follow Contact Point Twitter FDA Drug Information Receive the latest drug information from the US FDA Regulatory References Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more SBIA Learn Online Training Repository Search for conferences, webinars, online courses, newsletters and podcasts SBIA on LinkedIn Stay connected and receive regulatory updates and event notifications SBIA Learning Library on YouTube Browse conference and webinar recordings on YouTube Guidances Related to Drugs Documents representing FDA's thinking on a particular subject Drug Approvals and Databases Approvals and medications – Drugs@FDA, FDALabel, Orange Book, and more Development & Approval Process Drug applications, submissions, manufacturing, and small business help Advisory Committees Independent opinions and recommendations from outside experts on applications to market new drugs and on FDA policies