FDA & NIH: Regulatory Do's & Don'ts Webinar 📝

This inaugural webinar was a collaborative effort between FDA and NIH’s Small Business Innovation Research (SBIR) Development Center within the National Cancer Institute (NCI). Its purpose was to educate early-stage companies (small businesses) new to the regulatory landscape at the FDA. The genesis of this webinar can be attributed to the work that FDA, specifically SBIA, has contributed to NIH | SBIR in the past few years, and more recently with its Connecting Awardees with Regulatory Experts (CARE) Program.

Timestamps

13:55 – An Oncology Drug Development Mindset – First Steps

24:24 – Overview of CDER Regulatory Resources CMC for pre-IND/IND Submissions

35:00 – Overview of CDER Nonclinical Resources and Guidance for Approaching First-in-Human (FIH) Studies

45:33 – CDER’s Clinical Consideration for First-in-Human Trials

55:56 – Session I Q&A Panel

Speakers | Panelists:

Jeff Summers, MD
Associate Office Director
Office of Oncologic Diseases (OOD)
Office of New Drugs (OND | CDER

Paresma Patel, PhD
Division Director
Office of Product Quality Assessment III (OPQA III)
Office of Pharmaceutical Quality (OPQ) | CDER

Emily Wearne, PhD
Pharmacologist/Acting Nonclinical Team Leader
Division of Hematology Oncology Toxicology (DHOT)
OOD | OND | CDER

Caitlin Tydings, MD
Pediatric Hematologist/Oncologist
Medical Officer, Division of Oncology 3
OOD | OND | CDER

Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/fda-nih-regulatory-dos-and-donts-tips-fda-09042024

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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 - https://www.fda.gov/cdersbia
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Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367