FDA has released the Form FDA-483 with one observation from a 5/12-5/19 inspection at the Lonza Bend manufacturing facility in Bend, OR. The inspection observation was:
Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the draft PDUFA 8 commitment letter. The PhRMA comment says PDUFA 8 will help ensure the long-term sustainability of FDA’s human drug review program and strengthen agency capabilities by: * enhancing the efficiency of the drug review process
CDRH is accelerating hiring after losing about 22% of its workforce over the past year and a half, including up to 30% of its clinical reviewers and significant numbers of artificial intelligence and digital health specialists. CDRH drector Michelle Tarver disclosed the staffing losses 10/21 at AdvaMed's
The Bipartisan Policy Center (BPC) says it supports FDA’s goal of a risk-based, least-burdensome approach that gives patients timely access to safe and effective generative artificial intelligence (AI) device functions. Responding to an FDA discussion paper on the subject, BPC makes these key points: * several approaches in
Researchers from Johns Hopkins and the University of Miami say myelodysplastic syndromes (MDS) therapeutic development is challenged by the syndromes’ biological diversity and regulatory risk. Writing in Blood Advances, the researchers say MDS is “ideal for FDA to implement flexible, biology-informed regulatory pathways. Establishing such frameworks in MDS could