U.S. Food and Drug Administration | FDA | NIH: Regulatory Do’s and Don'ts: Tips from FDA – CDER Segment @US_FDA | Uploaded 1 week ago | Updated 6 hours ago
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: 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 - fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist - youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - fda.gov/cdersbialearn
Twitter - twitter.com/FDA_Drug_Info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
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: fda.gov/drugs/news-events-human-drugs/fda-nih-regulatory-dos-and-donts-tips-fda-09042024
-----------------------
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 - fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist - youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - fda.gov/cdersbialearn
Twitter - twitter.com/FDA_Drug_Info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
