2017 SBIA Webinars
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft guidance for Industry: Information Requests and Discipline Review Letters Under GDUFA
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - REMS Integration Initiative: An Overview - December 4, 2017
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Optimizing Your Study Data Submissions to FDA Study Data Technical Conformance Guide October 2017 Version Update - November 8, 2017
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Determining Whether to Submit an ANDA or 505(b)(2) Application
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: ANDA Submissions - Amendments to Abbreviated New Drug Applications Under GDUFA II
- CDER SBIA extended webinar: Electronic Drug Registration & Listing Using CDER Direct - October 5, 2017
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Optimizing Your Study Data Submissions to FDA - Updates from CDER and CBER - July 13th 2017 - 1:00pm - 2:45pm (Eastern)
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - The Ins and Outs of Presenting Clinical Pharmacology Information in Prescription Drug Labeling - June 19th 2017 - 1:00pm - 2:30pm (Eastern)
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive - June 15th 2017 - 12:00pm - 3:00pm (Eastern)
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - CDER Microbiology Issues: A Deeper Dive - March 15th, 2017