The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) in conjunction with the National Institutes of Health (NIH) will host a webinar entitled Regulatory Do’s and Don’ts: Tips from FDA.
The webinar aims to educate early-stage companies (small businesses) new to the regulatory landscape at the FDA. This activity is intended to provide an overview on resources and programs that FDA has developed across the Center for Biologics Evaluation and Research (CBER), CDER, and the Center for Devices and Radiological Health (CDRH) that can help academic life-science accelerators and early-stage, oncology-related companies develop new anticancer-therapeutics, devices, and diagnostics. Additionally, there will be a Q&A at the end of each session for the audience to ask questions.
Topics will include:
- Regulatory resources and early engagement programs available at FDA centers (CBER, CDER, and CDRH)
- Chemistry, Manufacturing, and Controls (CMC), non-clinical, and clinical guidance documents for early product development
- Early-stage
- Small molecule drug and biologic anticancer-drug development
- Cell and gene therapy anticancer-drug development
- Anticancer-device and diagnostic development
Additional details:
Attendance is virtual, and continuing education credits are available. The webinar is free, but registration is required. The intended audience is academic spin-off and early-stage companies (small businesses) developing therapies, devices, diagnostics, and digital health technologies as well as researchers and health care professionals developing new anti-cancer drugs.