CDER Small Business and Industry Assistance Overview (12of14) REdI 2018

CDER’s Renu Lal shares industry educational resources and FDA points of contact for assistance. _______________________________ 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 2018 Playlist:    • 2018 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

The Active IND and Available Development Programs (13of14) REdI 2018
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The Active IND and Available Development Programs (13of14) REdI 2018

AGDD 2025 | D1S02 - Novel Bioequivalence Study Design Recommendations
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AGDD 2025 | D1S02 - Novel Bioequivalence Study Design Recommendations

503B Product Reporting for Compounding Outsourcing Facilities (7/7) Drug Registration & Listing 2018
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503B Product Reporting for Compounding Outsourcing Facilities (7/7) Drug Registration & Listing 2018

Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers
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Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers

FDA Direct: Faster Reviews, Food Dye Wins and Protecting American DNA
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FDA Direct: Faster Reviews, Food Dye Wins and Protecting American DNA

GDUFA II Training IR and DR Letters, Michael Folkendt
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GDUFA II Training IR and DR Letters, Michael Folkendt

AGDD 2025 | D1S01 - Product-Specific Guidance for Complex Products: From Research to Standards
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AGDD 2025 | D1S01 - Product-Specific Guidance for Complex Products: From Research to Standards

Financial Transparency & Efficiency of the Prescription Drug, Biosimilar, & Generic Drug User Fees
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Financial Transparency & Efficiency of the Prescription Drug, Biosimilar, & Generic Drug User Fees

AGDD 2025 | D2S03 - Common Deficiencies and Resolutions: Complex Drug Substance/Excipients/Products
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AGDD 2025 | D2S03 - Common Deficiencies and Resolutions: Complex Drug Substance/Excipients/Products

AGDD 2025 | D2S04 - Nitrosamines: Known Issues and Practical Advice
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AGDD 2025 | D2S04 - Nitrosamines: Known Issues and Practical Advice

Study Data Submissions: Office of Vaccines Research and Review (OVRR) Data Submission – May 8, 2018
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Study Data Submissions: Office of Vaccines Research and Review (OVRR) Data Submission – May 8, 2018

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

193rd Vaccines and Related Biological Products Advisory Committee Meeting
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193rd Vaccines and Related Biological Products Advisory Committee Meeting

FDA Grand Rounds: FDA Menopausal Hormone Therapy (MHT) Labeling: Historical Context & Recent Changes
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FDA Grand Rounds: FDA Menopausal Hormone Therapy (MHT) Labeling: Historical Context & Recent Changes

AGDD 2025 | D2S03-1 Session 3: Q&A Discussion Panel
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AGDD 2025 | D2S03-1 Session 3: Q&A Discussion Panel

FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
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FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers

Office of New Drugs Custom Medical Queries(OCMQs) for Safety Signal Detection in Clinical Trial Data
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Office of New Drugs Custom Medical Queries(OCMQs) for Safety Signal Detection in Clinical Trial Data

AGDD 2025 | D2S05 - Workshop Closing Remarks
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AGDD 2025 | D2S05 - Workshop Closing Remarks

AGDD 2025 | D1S01 – Session 1: Q&A Discussion Panel
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AGDD 2025 | D1S01 – Session 1: Q&A Discussion Panel

Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications
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Office of New Drugs Standard Safety Tables and Figures for New Drug and Biologic Applications