Decision to replace the rosiglitazone REMS’ distribution restrictions with prescriber training reflected a consensus opinion shared by leadership in three CDER offices, despite a poll of reviewers who participated in a June advisory committee meeting and favored eliminating the risk management program.
FDA opted to modify the Risk Evaluation and Mitigation Strategy for GlaxoSmithKline PLC’s Avandia and other rosiglitazone-containing medicines despite an internal poll of review staff that showed a preference for eliminating the risk management program altogether.
Five of 11 FDA reviewers across a variety of disciplines favored removing the existing REMS with elements to assure safe...
HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.
The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?
Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
