FDA clinical trial coordinators

FDA clinical trial coordinators

Is responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of the Principal Investigator (PI). Good Clinical Practices Principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health…

FDA clinical trial penis

FDA clinical trial penis

Auxilium Pharmaceuticals Inc. (AUXL) won approval to expand use of its hand-disorder drug Xiaflex to treat men with curvature of the penis from a painful buildup of scar tissue. The company’s shares climbed on the approval. The Food and Drug Administration…

FDA clinical trial sponsor

FDA clinical trial sponsor

The slides accessed through the links below provide annual bioresearch monitoring (BIMO) inspection metrics by fiscal year (FY). The inspectional data cover all aspects of FDA’s BIMO program (i.e., clinical investigators, IRBs, sponsors, bioequivalence…

Clinical trials and FDA Approval

Clinical trials and FDA Approval

The Clinical Trials Database is a standardized dataset of information about the clinical studies and trials conducted in support of Premarket Approval (PMA). When complete, it will be able to be used by patients, healthcare providers, researchers and…

FDA clinical trial Glossary

FDA clinical trial Glossary

Adverse Reaction: (Adverse event.) An unwanted effect caused by the administration of drugs. Adverse reactions may occur suddenly or develop over time. Approved Drugs: In the United States, the US Food and Drug Administration (FDA) must approve a drug…

Clinical trials for medical devices FDA

Clinical trials for medical devices FDA

At FDA’s Center for Devices and Radiological Health (CDRH), results from clinical trials often serve as the foundation for our decisions to approve the most important medical devices—devices, such as implantable heart devices, that carry the greatest…