2 min read
When an oncology drug is tested, the signal is often brutally clear. A tumor either shrinks on a scan or it does not. A patient either lives or does not. In psychiatric drug development, the endpoints are almost never so crisp. In PTSD trials in...
2 min read
In August 2024, the FDA declined to approve MDMA-assisted therapy for post-traumatic stress disorder. The decision followed a June advisory committee meeting in which panelists voted nine to two that the data had not shown MDMA was effective, and ten to...
4 min read
March 2026 regulatory updates underscore newly published final and draft guidances focused on real-world data, safety reporting, biosimilars, CGMP inspections, and innovative drug development methods. It also highlights industry news and regulatory...
3 min read
In February 2026, FDA activity included new draft guidances, regulatory initiatives (e.g., PreCheck and eCTD 4.0), continued focus on innovation areas like rare diseases and AI, multiple drug approvals (including new molecular entities), and an upcoming...
3 min read
January 2026 regulatory updates underscored evolving AI-focused policies, ongoing scrutiny of evidentiary standards, strengthened compliance expectations, several product approvals, and advanced review modernization initiatives. The month also introduced...
4 min read
December 2025 capped the year with a robust slate of FDA activity, including multiple final and draft guidances addressing labeling, safety reporting, clinical trials, and real-world evidence, alongside notable regulatory news and multiple drug and...
3 min read
November brought significant FDA activity, with new final and draft guidances—from Pre-RFD updates to cross-center master files and Q3E leachables—alongside notable RAPS coverage, leadership changes, regulatory developments, and multiple high-impact drug...
3 min read
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...
5 min read
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...
4 min read
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...