Mozobil® (Plerixafor, AMD3100), 10 years after its approval by the US Food and Drug Administration

The US Food and Drug Administration Cardiorenal Advisory Panel and the drug approval process.

New chemical entities developed by the pharmaceutical industry as potentially useful drugs undergo extensive preclinical evaluation followed by clinical trials to evaluate efficacy and safety in human subjects. In the United States, the Food and Drug Administration (FDA) is charged with evaluating requests from pharmaceutical sponsors for approval to market new drugs or to expand indications fo...

US Food and Drug Administration and design of drug approval studies.

Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies.

IMPORTANCE Postmarketing surveillance is critical to evaluating the safety and effectiveness of medical devices. The US Food and Drug Administration (FDA) may order the manufacturer of a high-risk device to conduct postmarketing surveillance studies, known as postapproval studies (PASs), at the time of approval. OBJECTIVES To understand the characteristics of PASs ordered in recent years and ...

US Food and Drug Administration approval of ciprofloxacin hydrochloride for management of postexposure inhalational anthrax.

In August 2000, the US Food and Drug Administration (FDA) approved ciprofloxacin hydrochloride (Cipro; Bayer) for management of postexposure inhalational anthrax. This was the first antimicrobial drug approved by the FDA for use in treating an infection due to a biological agent used intentionally. The terrorist attacks of 2001 involving anthrax underscore the imperative that safe and effective...

Dorsal root ganglion stimulation approval by the Food and Drug Administration: advice on evolving the process.

Dorsal root ganglion stimulation approval by the Food and Drug Administration: advice on evolving the process Timothy R. Deer & Jason E. Pope To cite this article: Timothy R. Deer & Jason E. Pope (2016) Dorsal root ganglion stimulation approval by the Food and Drug Administration: advice on evolving the process, Expert Review of Neurotherapeutics, 16:10, 1123-1125, DOI: 10.1080/14737175.2016.12...