Materials and recordings from recent events:
- January 22, 2025 Webinar: BsUFA III Regulatory Science Pilot Program: Progress Update
- Webinar Recording (coming soon)
- Slides from Webinar
- December 10-12, 2024: FDA Clinical Investigator Training Course (CITC) 2024
- November 21, 2024 Webinar: M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms:
Implementing the Final Guidance - November 7, 2024 Webinar: Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation
- October 16, 2024 Webinar: Global IDMP Implementation – Getting Closer to the Goal
- October 9, 2024 Webinar: ICH M12 Drug-Drug Interaction Studies Final Guidance
- September 24-25, 2024: Advancing Generic Drug Development: Translating Science to Approval 2024
- September 12, 2024: Electronic Drug Registration and Listing (eDRLS) Using CDER Direct 2024
- September 4, 2024 Webinar: FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA
- July 30, 2024 Webinar: Environmental Monitoring in Compounding
- July 23, 2024 Webinar: Introduction to FDA’s Office of Trade and Global Partnerships
- June 26, 2024 Webinar: Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule
- June 18, 2024 Webinar: OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration
- June 13, 2024 Webinar: OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice
- May 29-30, 2024: Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development
- May 16, 2024 Webinar: Statistical Considerations for Premarketing Risk Assessment
- May 9, 2024 Webinar: Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval
- April 25, 2024 Webinar: Facilitating Generic Drug Product Development through Product-Specific Guidances
- April 10-11, 2024: Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access
- March 7, 2024 Webinar: Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes
- February 28, 2024 Webinar: Expanding Generic Drug Access Through International Engagements
- February 22, 2024 Webinar: Joint US FDA – Health Canada ICH Public Meeting
- February 13-15, 2024: A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Symposium
- January 18, 2024 Webinar: A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs
- December 12-13, 2023 Webinar: Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources
- December 6 – 7, 2023: FDA Clinical Investigator Training Course (CITC)
- November 28, 2023 Webinar: Toward Global IDMP Implementation: A Focus on Global Use Cases
- November 16, 2023 Webinar: Common Issues with SEND Data Submitted for Safety Pharmacology Studies
- Oct 31 – Nov 1, 2023: Pharmaceutical Quality Symposium: Quality, Supply Chain & Advanced Manufacturing
- October 16, 2023 Webinar: BsUFA III Regulatory Science Pilot Program
- October 11, 2023: 2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials
- September 28, 2023: Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2023
- September 13-14, 2023: Advancing Generic Drug Development: Translating Science to Approval 2023
- September 6, 2023 Webinar: Understanding FDA Inspections and Data
- August 22, 2023 Webinar: OTC Monograph Reform: OMOR Format and Content & Electronic Submissions
- June 20, 2023 Webinar: Decentralized Clinical Trials (DCT) Draft Guidance
- June 15, 2023 Webinar: Overview: Clinical Pharmacology Considerations for Food Effect Studies
- June 5-9, 2023: Regulatory Education for Industry (REdI) Annual Conference 2023
- May 24, 2023 Webinar: An Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)
- May 16, 2023 Webinar: OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration
- May 15, 2023 Webinar: A Deep Dive: GDUFA III Scientific Meetings
- May 2, 2023 Webinar: Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”
- April 25, 2023 Webinar: Electronic Systems, Electronic Records, and Electronic Signatures
- April 19 & 20, 2023 Webinar: FDA’s Dosage and Administration Section of Labeling Draft Guidance
- April 12-13, 2023: FDA Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF
- March 14, 2023 Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence
- February 24, 2023: Joint US FDA – Health Canada ICH Public Meeting
- February 15, 2023 Webinar: Overview: Clinical Pharmacology Considerations for Neonatal Studies
- February 1, 2023 Webinar: Overview of FDA’s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use
- January 26, 2023 Webinar: FDA’s Labeling Resources for Human Prescription Drugs
- January 13, 2023 Webinar: Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards
- December 14, 2022 Webinar: What to Expect after an Inspection: 483s, Responses and Beyond
- December 7-8, 2022: FDA Clinical Investigator Training Course (CITC) 2022
- November 30, 2022: Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions
- October 26, 2022 Webinar: An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations
- October 11, 2022: FDA NanoDay Symposium 2022
- October 5, 2022 Webinar: Study Data Standards Update for CBER: Your Guide to a Successful Submission
- September 20-21, 2022: Advancing Generic Drug Development Workshop: Translating Science to Approval
- September 8, 2022 Webinar: Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act
- August 16-18, 2022: Regulatory Best Practices for Global Access to Medicines,
Including Anti-TB Medicines Conference - August 11, 2022 Webinar: Best Practices for Topical Generic Product Development and ANDA Submission
- August 10, 2022 Webinar: Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
- July 19-20, 2022: Office of Study Integrity and Surveillance Workshop
- June 6-10, 2022: REdI Annual Conference 2022
- May 24 & 25, 2022: Quality Management Maturity Workshop
- May 11, 2022 Webinar: US-Canada Regional ICH Consultation
- April 26-27, 2022: Generic Drugs Forum
- April 6, 2022 Webinar: FDA Inspections of Outsourcing Facilities
- March 29, 2022 Webinar: OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings
- March 16, 2022 Webinar: FDA-EMA Parallel Scientific Advice (PSA) Program
- February 24, 2022 Webinar: BE Studies with PK Endpoints for Drugs Submitted Under an ANDA
- February 16, 2022 Webinar: CDER BIMO GCP Compliance and Enforcement
- February 10, 2022 Webinar: Digital Health Technologies (DHTs) for Remote Data Acquisition Draft Guidance
- January 27, 2022 Webinar: Toward Global Identification of Medicinal Products (IDMP) Implementation: A Focus on Biologics
- December 15, 2021 Webinar: OTC Monograph Reform: Deemed Final Orders
- December 8, 2021 Webinar: Operational Updates for Clinical Investigators
- December 7, 2021 Webinar: Scientific Updates for Clinical Investigators
- October 26-27, 2021: Pharmaceutical Quality Symposium
- October 13, 2021: Electronic Drug Registration and Listing Using CDER Direct Workshop
- October 5, 2021 Webinar: Enhanced Drug Distribution Security in 2023 Under the DSCSA:
Grouped Submissions - September 21-22, 2021: Advancing Generic Drug Development Workshop
- August 31, 2021 Webinar: Promotional Submissions in eCTD Format:
Grouped Submissions - August 25, 2021 Webinar: Manufacturing, Supply Chain, and Inspections
during the COVID19 Public Health Emergency - Webinar Recordings:
- Part 1: FDA guidance on manufacturing during COVID-19 and high absenteeism
- Part 2: Risk management and application approaches in responding to supply chain constraints during PHE
- Part 3: Inspections and use of alternate tools during the PHE
- Slides from Webinar
- July 19-23, 2021: REdI Annual Conference
- June 23, 2021: Generic Drug Science and Research Initiatives Public Workshop
- June 11, 2021 Webinar: Identification of Medicinal Products:
Path to Global Implementation - June 3, 2021 Webinar: OTC Monograph Drug User Fee Program (OMUFA):
Understanding FY 2021 User Fees Webinar - May 21, 2021 Webinar: FDA Study Data Technical Rejection Criteria (TRC):
What you need to know! - May 14, 2021 Webinar: FDA and Health Canada Regional ICH Consultation
- Webinar Recordings: Part One and Part Two
- Slides from Webinar
- May 7, 2021 Webinar: Common Labeling Deficiencies and Tips for Generic Drug Applications
- May 5, 2021 Webinar: Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs Webinar
- Agenda and Speaker Bios
- Webinar Recordings:
- Opening Remarks – Lei Zhang
- Overview of the FDA Product-Specific Guidance Program – Christine Le
- Non-Complex Drug Products and Product-Specific Guidances – Myong-Jin Kim
- Product-Specific Guidances for Complex Generic Drugs – Markham Luke
- Product-Specific Guidance Fundamentals from a Clinical Perspective – Mitch Frost
- Developing and Implementing Science-Based Standards in Bioequivalence Assessment – Paramjeet Kaur
- Bioequivalence Regulations and Product-Specific Guidances – Dave Coppersmith
- Closing Remarks – Robert Lionberger
- Q&A and Panel Discussion – All presenters joined by Bing Li
- Slides from Webinar
- April 28 & 29, 2021: Generic Drugs Forum
- April 9, 2021 Webinar: Drug Master File and Drug Substance Workshop: Follow-Up Webinar
- March 30 & 31, 2021: Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups
- March 3 & 4, 2021: Drug Master File (DMF) and Drug Substance Workshop (and Follow-Up Webinar)
- February 19, 2021 Webinar: FDA Safety Report Type Flag Requirement for FAERS Submissions
- January 29, 2021 Webinar: Regulatory Perspectives for Development of Drugs for Treatment of NASH
- January 27, 2021 Webinar: OTC Monograph Reform in the CARES Act: Safety Orders
- January 2021: CDER Compliance Conference
2020:
- December 16, 2020 Webinar: Diversity in Clinical Trials
- December 4, 2020 Webinar: SEND for CBER, What You Need to Know
- November 20, 2020 Webinar: Office of Prescription Drug Promotion – Core Launch Review Process
- November 13, 2020 Webinar: Bridging the Gap – Promoting Safe and Effective Prescription Drug Use in Geriatric Patients
- November 6, 2020 Webinar: Office of New Drug (OND) Research: Seeking Collaborators, Funding Opportunities Available
- Webinar Recordings: Session One and Session Two
- Slides from Webinar
- October 2020: Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book
- October 15 & 16, 2020 Webinar: New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment
- Webinar Recordings: Day One Recording; Day Two Recording
- Slides from Webinar
- October 2020: Electronic Drug Registration and Listing Using CDER Direct
- October 2, 2020 Webinar: Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs
- September 2020: Advancing Innovative Science in Generic Drug Development Workshop
January 2020 – August 2020: Click here to view recordings of those 2020 SBIA events
- August 2020: REdI Annual Conference 2020
- June 2020: Regulated Bioanalysis Workshop
- June 15, 2020 Webinar: CDER SEND Common Issues and Policy Update
- June 2020: Pharmacovigilance and Risk Management Conference
- May 29, 2020 Webinar: Monograph Reform is Here!
- April 29, 2020 Webinar: Postmarketing Drug Safety Compliance: 2019 Inspection Findings
- April 24, 2020 Webinar: Updates on FDA’s Drug-Drug Interaction Final Guidances
- April 2020: Generic Drugs Forum
- March 6, 2020 Webinar: ClinicalTrials.gov Modernization and How to Provide Input
2019: Click here to view recordings of all 2019 SBIA events
- December 2019: CDER Prescription Drug Labeling Conference
- November 22, 2019 Webinar: The FDA Study Data Technical Conformance Guide v4.4
- November 1, 2019 Webinar: Submitting IND Safety Reports to FAERS
- October 25, 2019 Webinar: Promotional Submissions in eCTD Format: Common Errors and Validation
- October 2019: Electronic Drug Registration and Listing Using CDER Direct
- October 2019: Pharmaceutical Quality Symposium
- October 11, 2019 Webinar: e-Submissions to FAERS using ICH E2B(R3) Standards
- September 2019: Complex Generic Drug Product Development Workshop
- September 12, 2019 Webinar: Most Common Issues with CDISC-SEND Data in FDA Toxicology Review
- June 17, 2019 Webinar: An FDA Perspective on the Bioanalytical Method Validation
- June 13, 2019 Webinar: Identification of Medicinal Products
- June 10, 2019 Webinar: Financial Incentives for CDER Medical Products
- May 2019: REdI Annual Conference 2019
- May 9, 2019 Webinar: Introduction to the FDA MyStudies App
- April 2019: Generic Drugs Forum 2019
- March 15, 2019 Webinar:Framework for FDA’s Real-World Evidence Program
2018: Click here to view recordings of 2018 SBIA events
- December 6, 2018 Webinar: Use of EHR Data in Clinical Investigations
- November 27, 2018 Webinar: FDA Study Data Technical Conformance Guide
- FDA & MHRA Good Clinical Practice Workshop 2018
- October 2018: Electronic Drug Registration & Listing Using CDER Direct
- September 27, 2018 Webinar: “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance
- September 2018: Complex Generic Drug Product Development Workshop
- June 19, 2018 Deeper Dive Webinar: Postmarketing Drug Safety and Inspection Readiness
- Slides from the Webinar (PDF): Morning Session Slides, Afternoon Session Slides
- May 2018: REdI Conference 2018
- May 8, 2018 Webinar: Optimizing Your Study Data Submissions to FDA: OVRR Data Submission
- April 2018: Generic Drugs Forum 2018
2017: Click here to view recordings of 2017 SBIA events
- December 4, 2017: REMS Integration Initiative: An Overview Webinar
- November 8, 2017: Optimizing Your Study Data Submissions to FDA –Study Data Technical Conformance Guide October 2017 Version Update Webinar
- November 1 & 2: Prescription Drug Labeling Conference 2017
- October 5, 2017: Electronic Drug Registration & Listing Using CDER Direct Extended Webinar
- September 2017: REdI Fall Conference 2017
- July 13, 2017: Optimizing Your Study Data Submissions to FDA Webinar
- June 19, 2017: Clinical Pharmacology Information in Prescription Drug Labeling Webinar
- June 15, 2017: REMS: A Deeper Dive Webinar
- May 2017: REdI Spring Conference 2017
- April 2017: Generic Drugs Forum 2017
- March 2017: CDER Microbiology Issues: A Deeper Dive Webinar
2016:
- November 21, 2016: Electronic Submission requirements for ANDAs: Are you ready?
- October 28, 2016: Overview of GDUFA II and Implementation of GDUFA II User Fees
- October 12, 2016: Study Data Standards in eCTD: What You Need to Know About the New Technical Rejection Criteria
- September 27-28, 2016: REdI Fall Conference 2016
- August 24, 2016: Submitting Risk Evaluation and Mitigation Strategies (REMS) in Structured Product Labeling (SPL) Format: What You Need to Know
- August 4, 2016: Stay Compliant! Electronic Submission of Drug Master Files (DMFs) is MANDATORY starting May 5, 2017: What You Need to Know
- July 20-21, 2016: Pharmaceutical Quality Symposium 2016
- April 13-14, 2016: Generic Drugs Forum 2016
- February 4, 2016: New Requirement for Electronic Submission of Drug Master Files (DMFs): What You Need to Know
2015:
- October 8, 2015: Required Electronic Submissions: eCTD and Study Data
- September 29-30, 2015: REdI Fall Conference
- July 15-16, 2015: Focus on CGMPs & FDA Inspections
- July 7, 2015: Source Data Capture from Electronic Health Record Confirmation
- April 22-23, 2015: Generic Drugs Forum 2015
For information on all previous SBIA events, visit: