Gottlieb On Medical Marijuana: Smoking Is Not Effective Way To Deliver API
Executive Summary
US FDA Commissioner tells Congress that agency is 'very open' to considering use of active ingredients in marijuana to ease chronic pain.
You may also be interested in...
Cannabinoid Market Snapshot: GW's Epilepsy Success Bodes Well
Over 50 cannabinoid drugs are in development, most commonly targeting central nervous system diseases. Analysts think the relaxation of restrictions on medical cannabis is helping with perception problems, but so far there’s little evidence the market isn’t just smoke and mirrors.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.
Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says
Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.