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

September 4, 2024

About This Course

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 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 that could benefit from support in better understanding when to contact the Agency during preclinical development. Additionally, there will be a Q&A session at the end of each session for the audience to ask questions.

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 Covered

• 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

Resources

• NCI SBIR Development Center website with curated list of links to FDA resources for early-stage product developers
• CDER Small Business and Industry Assistance (SBIA)
• CDRH Division of Industry and Consumer Education (DICE)
• CBER Manufacturers Assistance and Technical Training Branch (MATTB)

visit the FDA.gov webpage