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SUMMARY:FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA
DESCRIPTION: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. \nIntended Audience\n\nAcademic spin-off and early-stage companies (small businesses) developing therapies\, devices\, diagnostics\, and digital health technologies.\nResearchers developing new anti-cancer drugs.\nHealthcare professionals developing new anti-cancer drugs.\n\nTopics\n\nRegulatory resources and early engagement programs available at FDA Center (CBER\, CDER\, and CDRH)\nChemistry\, Manufacturing\, and Controls (CMC)\, non-clinical\, and clinical guidance documents for early product development.\nEarly-stage\n\nSmall molecule drug and biologic anticancer-drug development.\nCell and gene therapy anticancer-drug development.\nAnticancer-device and diagnostic development.\n\n\nQ&A session with FDA regulators
URL:https://ventures.jhu.edu/event/fda-nih-regulatory-dos-and-donts-tips-from-fda/
LOCATION:Virtual\, United States
CATEGORIES:Education Programs,Pava Center
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