Air quality has a huge impact on health, with exposure to particles with an aerodynamic diameter of < 1 µm (PM1) significantly increasing the number of […]
TOPLINE: CD37, a surface protein present on most acute myeloid leukemia (AML) blasts, demonstrates unique internalization properties that enable targeted drug delivery with minimal impact on […]
Image CaptionAttendees participate in this annual training course where they learn best practices for ensuring data quality and integrity in BSL-4 facilities. Current course | Background […]
For Immediate Release: January 14, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the […]
Postmarketing Requirements and Commitments Postmarket requirement and commitment studies and clinical trials occur after a drug or biological product has been approved by FDA. Under various […]
Q: According to the program’s eligibility criteria, proposed RWE studies should be intended to meet regulatory requirements in support of labeling for effectiveness (e.g., new indications, […]
HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this […]
Image Medical and veterinary products save lives every day. FDA-regulated products such as blood pressure medicine, chemotherapy and MRI machines help people and animals live longer […]
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