CDER Small Business & Industry Assistance (SBIA)

CDER Small Business & Industry Assistance (SBIA) A Comprehensive Resource for Information on Human Drug Development in Regulation Register for Upcoming Events | Date | Time | Event | Location | |---|---|---|---| | 4/15/2026 | 1:00 pm-2:30 pm ET | Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers | Virtual | | 4/22/2026 and 4/23/2026 | 9:00 am-5:00 pm ET | Generic Drugs Forum (GDF) 2026 | In-Person and Virtual | | 5/5/2026 | 1:00 pm-2:00 pm ET | OTC Monograph Drug User Fee Amendments (OMUFA): Understanding FY 2026 User Fees and Registration | Virtual | | 5/19/2026 and 5/20/29 | 9:00am-4:50 pm ET (Day 1) and 9:00-3:50 p.m. ET (Day 2) | Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products | In-Person and Virtual | Regulatory References, Training, and Resources 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 On-Demand Learning Library Browse conference and webinar recordings on YouTube Popular Topics 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 Division of Drug Information Office of Communications 10001 New Hampshire Ave Hillandale Building, 4th Fl Silver Spring, MD 20993 For Latest Updates Follow FDA Drug Information Receive the latest drug information from the US FDA