ES10.01 US Food and Drug Administration

The US Food and Drug Administration and probiotics: regulatory categorization.

Probiotics are living microorganisms that, when consumed, have the potential to confer a beneficial health effect. Unfortunately for purveyors of probiotic products, the system of regulation delineated in the Food, Drug, and Cosmetic Act is anything but "one size fits all." How a probiotic product is used or is intended to be used will govern the regulatory category or categories that the US Fo...

Crisis deepens at the US Food and Drug Administration.

BMJ VOLUME 329 4 DECEMBER 2004 bmj.com The US Food and Drug Administration, rocked by controversy in recent months, has now admitted that a senior management official secretly contacted a whistleblower group. That official attempted to discredit Dr David Graham, the FDA’s scientist who criticised the agency during US Senate hearings, saying that the FDA failed to protect the public when it appr...

US Food and Drug Administration Perspectives on Clinical Mass Spectrometry.

Mass spectrometry-based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical mass spectrometry community to improve th...

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.