Module 1:An Overview of the U.S. Food and Drug Administration
Presented by Zoe Kosmidis, Regulatory Policy Manager, Biocom
Regulatory Policy
Biocom’s Federal, State and Regional Policy teams advocate for policies that create a positive regulatory environment for California’s life science innovation ecosystem.
Advocating for a Positive Regulatory Environment
Biocom’s Policy team advocates for policies that create a positive regulatory environment for California’s life science innovation ecosystem.
Regulatory Policy determines significant rules, standards and procedures the life science community must follow. With member input, Biocom submits comment letters and feedback that support a healthy industry.
FDA 101: Learn about how drugs and devices are regulated in the United States
Biocom, in partnership with subject matter experts, has created a video series explaining how the U.S. Food and Drug Administration (FDA) regulates drugs, biological products and medical devices in the United States.
In this introductory series, you will learn firsthand about the FDA’s regulatory and classification framework for drugs, biologics and medical devices and ways to interact with the agency through the drug and device development processes.
Please fill out the form to unlock the videos.
The first series includes the following introductory videos:
Module 2:FDA’s Regulatory Framework for Drugs and Biologics
Presented by Michael Boyne, Co-Founder & Principal, CatalystBio
Module 3:Meetings, Pathways, and Designations for Drugs and Biologics
Presented by Greta Wodarcyk, Co-Founder & Principal, CatalystBio
Module 4:FDA’s Classification Framework and Premarket Pathways for Medical Devices
Presented by Amy Leiser, Special Counsel, Covington & Burling LLP
Module 5:General Controls and Postmarket Obligations for Medical Devices
Presented by Amy Leiser, Special Counsel, Covington & Burling LLP
Additional Regulatory Efforts
Regulatory Policy Initiatives
Engaging with federal agencies and connecting our members with high-level key regulators.
Writing letters that incorporate members’ priorities and feedback to advocate for regulatory policies that support California’s life science industry.
Creating advocacy resources that provide valuable regulatory insights to help members understand guidance and rulemaking and their potential impact on the life science community.
Providing support by connecting members with providers who can help address their specific regulatory needs and questions.
Join Our Regulatory Affairs Committee
Biocom’s Regulatory Affairs Committee (RAC) works to address regulatory and scientific issues faced by the life science community.
Open to Biocom members only, the RAC meets quarterly to share thoughts, opinions and best practices for navigating the U.S. regulatory landscape.
RAC members also review, comment and provide official positions on select legislative and regulatory proposals, rulemaking, and guidance documents.
Regulatory Resources
Visit our Concierge directory to find a list of service providers who can help with all your FDA and international regulatory needs.
Newsletters
Regulatory & Reimbursement Newsletter
Stay up to date on the latest regulatory news with Biocom’s monthly Regulatory & Reimbursement Newsletter.