USEFUL LINKS:
- FDA Approved Drugs - link to review available information posted by FDA, to include key reviews conducted by FDA to inform internal planning
- FDA Guidance Document Search - source to identify potentially relevant FDA-published guidance documents on key topics
- FDA Approved Cellular and Gene Therapy Products - list of licensed products from the Office of Therapeutic Products (OTP)
- FDA Advisory Committee Calendar/Meeting Materials - link to calendars of forthcoming advisory committee meetings as well as provision of presented slide decks from sponsors, FDA, etc
- National Comprehensive Cancer Network (NCCN) Guidelines - treatment guidelines, by cancer type
- International Conference on Harmonization (ICH) - Makes recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration bringing together the drug regulatory authorities and the pharmaceutical industry of Europe, Japan and the United States.
- Regulatory Affairs Professional Society (RAPS) - RAPS is an international membership organization for regulatory professionals who are working to ensure the safety, effectiveness and availability of healthcare products, including medical devices, pharmaceuticals and biotechnology.
- FDA Guidance Webinar Series - FDA's Guidance Webinar series aims to foster collaboration and transparency in the development of guidance documents through direct outreach to affected stakeholders
- FDA Meetings, Conferences and Workshops -Upcoming events, past meetings, meeting materials, and transcripts
- Drug Information Association (DIA) - Provides forums to exchange information and discuss current issues related to health products, technologies, and services. Also useful to identify industry-related training.
- Clinicaltrials.gov
- A registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.