ICH Q12 Guidance and Emerging Technology Program (11of16) Generic Drugs Forum 2020

Ashley Boam and Thomas O’Connor from CDER’s Office of Pharmaceutical Quality discuss ICH Q12 as it applies to generic drugs and CDER’s emerging technology program. Learn more at https://www.fda.gov/drugs/news-events... _______________________________ FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming training and free continuing education credits: https://www.fda.gov/cdersbia CDER SBIA 2020 Playlist:    • 2020 CDER Small Business and Industry Assi...   LinkedIn:   / cder-small-business-and-industry-assistance   Training resources: https://www.fda.gov/cderbsbialearn Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm... Email: [email protected] Phone: (301) 796-6707 I (866) 405-5367

Common CMC (Quality) Issues and How to Avoid Them Part I (12of16) Generic Drugs Forum
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Common CMC (Quality) Issues and How to Avoid Them Part I (12of16) Generic Drugs Forum

Understanding the Nutrition Facts Label, the Updated “Healthy” Claim, and Other Nutrition Claims
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Understanding the Nutrition Facts Label, the Updated “Healthy” Claim, and Other Nutrition Claims

Learn About ClinicalTrials.gov Modernization and How to Provide Input – Mar. 6, 2020
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Learn About ClinicalTrials.gov Modernization and How to Provide Input – Mar. 6, 2020

FDA Direct: The Power of Real-Time Clinical Trials
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FDA Direct: The Power of Real-Time Clinical Trials

CDER & CBER All Hands: Implementing the FDA's Plausible Mechanism Framework
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CDER & CBER All Hands: Implementing the FDA's Plausible Mechanism Framework

VRBPAC -- May 28 Meeting
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VRBPAC -- May 28 Meeting

Conversations on Cancer: Patient first = Project Facilitate
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Conversations on Cancer: Patient first = Project Facilitate

Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
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Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing

Pharmacovigilance in Practice   From Safety Signals to Regulatory Action 1080
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Pharmacovigilance in Practice From Safety Signals to Regulatory Action 1080

CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products

Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5of14) REdI 2018
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Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5of14) REdI 2018

Advancing Real-Time Clinical Trials
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Advancing Real-Time Clinical Trials

OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products
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OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products

CDER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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CDER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products

ClinicalTrials.gov: Essentials for Academic Medical Centers – Pre-recorded Training Video
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ClinicalTrials.gov: Essentials for Academic Medical Centers – Pre-recorded Training Video

Know Your Nutrition
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Know Your Nutrition

SEND for CBER, What You Need to Know
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SEND for CBER, What You Need to Know

Oncology Nurses - The Frontliners in Oncology
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Oncology Nurses - The Frontliners in Oncology

CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products

Process Validation and ICH Q7
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Process Validation and ICH Q7