FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area. These compliance programs […]

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 […]

The Office of the Chief Medical Officer (OCMO) is sharing the following lists of guidance documents for public review and input: Guidance documents we intend to […]

About OCMO Guidance Documents The Office of the Chief Medical Officer (OCMO) provides executive leadership, coordination, and oversight of FDA cross-cutting clinical and public health emergency-related […]