Health Care Providers Have Knowledge Gap On Biosimilars, Accelerated Approval
Executive Summary
FDA’s 2019 survey of 2,000 providers finds 31% do not know what biosimilars are and 30% of primary care physicians do not know what an accelerated approval drug is. Another survey of low- or non-internet users finds a toll-free number is the best way for them to find information about a drug’s risks.
You may also be interested in...
TV Drug Advertising Study Targets Those With Limited Or No Internet Use
US FDA will assess value of including 1-800 number and print ad in broadcast commercials; it is among 42 direct-to-consumer studies the agency has undertaken, 13 of which are in progress.
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.