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Online Sources of Information: Memberships, Guidance Documents and Online Trainings
FDA References:
FDA Searchable Database: FDA Guidance Documents listed by topic and also in a searchable database.
FDA Searchable Database: Forms
FDA Searchable Database: FDA Acronyms and Abbreviations
FDA Searchable Database (FDA's CDER Procedures): Manual of Policies and Procedures
FDA Searchable Database: Withdrawn FDA Guidance Documents
FDA Website: Electronic Regulatory Submissions and Review Helpful Links
FDA Searchable Database: Search for Regulatory References: Drugs
FDA Website: Newly Added Guidance Documents
FDA Trainings:
CDERLearn: Courses and Training Materials Provided by FDA's CDER
FDA Website: FDA Meetings, Conferences and Workshops
SBIA: FDA CDER Small Business and Industry Assistance
FDA YouTube Channel
FDA Podcasts and Newsfeeds: FDA covers a variety of key topics.
FDA Voices on Medical Products: FDA Perspectives on Current Topics
EMA Resources:
Guidelines: A Description of the EMA Guidelines and Links to Lists and the Searchable Database
News and Events: A summary of events at the EMA
SME Website: Small and Medium Size Enterprize (SME) Support
Health Canada Guidelines: List of all Health Canada Guidelines by Topic
ICH Guidelines: All ICH Guidelines provided by topic.
Regulatory Affairs Memberships:
Regulatory Affairs Professional Society (RAPS)
Drug Information Association (DIA)
The Organization of Professionals in Regulatory Affairs (TOPRA)
Food and Drug Law Institute (FDLI)
Regional US Memberships:
North Carolina Regulatory Affairs Forum (NCRAF)
Orange County Regulatory Affairs (OCRA)
Canada
The Canadian Association of Professional Regulatory Affairs (CAPRA)
Alerts and Newsletter Subscriptions to Consider:
FDA Email Alerts: Sign up for email Alerts from FDA based on selected topics
Endpoints News (free)
Fierce Biotech (free)
BioSpace Newsletter (free)
PharmaVoice (free)
EMA SME Newsletters (free)
The FDA Law Blog (free)
Seeking Alpha (free)
Set a "Google Alert" for Key Topics (free)
Pink Sheet (also In Vivo/ Scrip, etc)- Paid
DIA Daily (Requires DIA Membership)
Regulatory Focus (Requires RAPS Membership)
Regulatory Rapporteur (Requires TOPRA Membership)
BioCentury- Paid
Oncology Specific Resources:
Friends of Cancer Research (FOCR): White Papers and Meetings
American Society for Clinical Oncology (ASCO): Trainings, Clinical Data and Publications/Meetings
American Association for Cancer Research (AACR): Trainings, Clinical/NonClinical Data and Meetings
FDA Website/Resource: Oncology Regulatory Expertise and Early Guidance (OREEG)
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