Latest From Brenda Sandburg
Complaint lists host of problems with implementation of the rule that allows states to sponsor programs to import certain prescription drugs from Canada; at least six states have enacted legislation to sponsor these programs.
Sanofi R&D head John Reed says the company has kept 95% of patients on its nearly 400 clinical trials, started 59 studies, and benefited from its in-house drug supply management.
Pitfalls of using third-party hubs for reimbursement assistance, sharing preapproval data with patient groups, and promoting biosimilars with labeling carveouts are among the concerns noted by panelists at FDLI conference.
Companies should consider alternatives to in-person physician presentations given the risk of kickback violations, OIG says. Concerns addressed in Novartis corporate integrity agreement are broader than that case, Chief Counsel to the Inspector General Greg Demske explains in an interview.
A look at drugs the agency approved despite an advisory committee vote not to do so and how they compare to Biogen’s Alzheimer’s disease drug aducanumab.
New review process planned to launch next year. FDA officials and industry reps note re-emergence of FDA enforcement actions targeting internet-sponsored links.