FDA | NIH: Regulatory Do’s and Don’ts: Tips from the FDA

This 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 of resources and programs that FDA has developed across CBER, CDER, and CDRH that can help academic life-science accelerators and early-stage, oncology-related companies develop new anticancer-therapeutics, devices, and diagnostics. The target audience is entrepreneurs new to the FDA regulatory world who could benefit from support in better understanding when to contact the agency during preclinical development. There will also be a Q&A sessions.

INTENDED AUDIENCE

• Academic spin-off and early-stage companies (small businesses) developing therapies, devices, diagnostics, and digital health technologies.
• Researchers developing new anti-cancer drugs.
• Healthcare professionals developing new anti-cancer drugs.

TOPICS

• Regulatory resources and early engagement programs available at FDA Center (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.
• Q&A session with FDA regulators