2016 SBIA Webinars
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Annual Reporting Using CDER Direct: Technical Tips for Wholesale Drug Distributors and Third-Party Logistics Providers
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - An Overview of FDA's Guidance - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Revised Draft Guidance for Industry: Submission of Quality Metrics Data
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - What's New with Forms FDA 3542a and 3542?
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Electronic Submission Requirements for ANDAs: Are You Ready? - November 21, 2016
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Overview of GDUFA II and Implementation of GDUFA II User Fees - October 28, 2016
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Study Data Standards in eCTD: What You Need to Know about the New Technical Rejection Criteria - October 12, 2016
- SBIA Webinar - Study Data Standards in eCTD: What You Need to Know about the New Technical Rejection Criteria: Chinese translation (for reference only): Webinar
- SBIA Webinar - Study Data Standards in eCTD: What You Need to Know about the New Technical Rejection Criteria: Chinese translation (for reference only): Presentation Slides
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Establishment Registration and Listing for Human Drugs
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Submitting Risk Evaluation and Mitigation Strategies (REMS) in Structured Product Labeling (SPL) Format: What You Need to Know - August 24, 2016
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar: Stay Compliant! Electronic Submission of Drug Master Files (DMFs) is MANDATORY starting May 5, 2017: What You Need to Know - August 4, 2016
- CDER Small Business and Industry Assistance (SBIA) Webinar: CDER Direct Electronic Submission Portal: 503B Product Reporting (Compounding)
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Pilot Clinical Outcome Assessment Compendium - March 8th, 2016
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know - February 4, 2016
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry on Safety Assessment for IND Safety Reporting - February 1, 2016
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