FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA – CDRH Segment
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
01:26 – How Can DICE Help You?
19:47 – Medical Device Development Tools Program
32:44 – Medical Device Coverage Initiatives: Connecting with Payors via the Payor Communication Task Force
42:30 – Session III Q&A Panel
Speakers | Panelists:
Giselle Blanco
Consumer Safety Officer
Premarket Programs Branch (PPB)
Division of Industry and Consumer Education (DICE)
Office of Communication and Education (OCE) | CDRHJessica Mavadia-Shukla, PhD
Director | Medical Device Development Tools Program
Division of Partnerships and Innovation (DPI)
Office of Equity and Innovative Development (OEID)
Office of Strategic Partnerships and Technology Innovation (OST) | CDRHDanielle Fau, MSE
Senior Advisor for Technology and Innovation
Division of Health Equity (DHE) OEID | OST | CDRHLearn 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
SBIA Listserv – https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist – https://www.youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter - https://twitter.com/FDA_Drug_Info
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367
Read the full article at: www.youtube.com
Who We Are
Omnica Corporation is a privately-held design, engineering, and medical product development firm located in Irvine, California. The 28-person company is staffed with full-time employees and has been in operation since 1984. Our speciality is custom product development for the medical industry and industrial fields.
Our expertise is developing complex medical devices.Technical personnel at Omnica includes designers, mechanical engineers, electronic and software engineers, advanced R&D specialists, regulatory staff (for FDA documentation), machinists and model makers.