The Drug Safety and Risk Management and Dermatologic and Ophthalmic Drugs Advisory Committees will assess the risk management program Dec. 1 for lessons about implementing REMS containing elements to assure safe use and selecting assessment metrics.
Both the evolving nature and relative success of the iPLEDGE Risk Evaluation and Mitigation Strategy for the acne medication isotretinoin will be on display Dec. 1 as FDA asks two advisory committees to discuss what the program can teach about implementing REMS containing elements to assure safe use and selecting assessment metrics.
The Drug Safety and Risk Management and Dermatologic and Ophthalmic Drugs Advisory Committees will review iPLEDGE as a prelude to...
The CBER director rejected Pfizer’s assertions that pediatric dosing gaps, supply constraints and comparative mRNA content justify keeping the vaccine under emergency use authorization for younger children.
Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.
The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.
The European Medicines Agency says that Winlevi should be approved in the EU for treating acne, having previously turned the drug down.
Minoryx explained to Pink Sheet why it believes its resubmission for leriglitazone stands a stronger chance of approval, and highlighted the value of early dialogue with the regulators when it comes to rare diseases, where the understanding of the natural history and outcomes is often limited.
The agency is expected to give its final verdict on the Barth syndrome drug by the end of September. Stealth is seeking accelerated approval based on the path forward outlined in the FDA's May 2025 complete response letter.
