Report of the Special Counsel's investigation of allegations relating to the Bureau of Veterinary Medicine, Food and Drug Administration /

Cover title.

Tools for compliance for the medical device and in vitrol diagnostic product industries.

Mode of access: Internet.

From test tube to patient : new drug development in the United States.

Mode of access: Internet.

Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials.

A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials. In a breakout session, workshop attendees discussed necessary data elements and standards for the accurate measurement of DILI risk associated with new therapeutic agents in clinical trials. There was agreement that in order to achieve this goal the systematic acquisition of protocol-specified clinical measures and lab specimens from all study subjects is crucial. In addition, standard DILI terms that address the diverse clinical and pathologic signatures of DILI were considered essential. There was a strong consensus that clinical and lab analyses necessary for the evaluation of cases of acute liver injury should be consistent with the US Food and Drug Administration (FDA) guidance on pre-marketing risk assessment of DILI in clinical trials issued in 2009. A recommendation that liver injury case review and management be guided by clinicians with hepatologic expertise was made. Of note, there was agreement that emerging DILI signals should prompt the systematic collection of candidate pharmacogenomic, proteomic and/or metabonomic biomarkers from all study subjects. The use of emerging standardized clinical terminology, CRFs and graphic tools for data review to enable harmonization across clinical trials was strongly encouraged. Many of the recommendations made in the breakout session are in alignment with those made in the other parallel sessions on methodology to assess clinical liver safety data, causality assessment for suspected DILI, and liver safety assessment in special populations (hepatitis B, C, and oncology trials). Nonetheless, a few outstanding issues remain for future consideration.

US Food and Drug Administration approval of generic versions of complex biologics: implications for the practicing physician using low molecular weight heparins

Low-molecular-weight heparins (LMWHs) have shown equivalent or superior efficacy and safety to unfractionated heparin as antithrombotic therapy for patients with acute coronary syndromes. Each approved LMWH is a pleotropic biological agent with a unique chemical, biochemical, biophysical and biological profile and displays different pharmacodynamic and pharmacokinetic profiles. As a result, LMWHs are neither equipotent in preclinical assays nor equivalent in terms of their clinical efficacy and safety. Previously, the US Food and Drug Administration (FDA) cautioned against using various LMWHs interchangeably, however recently, the FDA approved generic versions of LMWH that have not been tested in large clinical trials. This paper highlights the bio-chemical and pharmacological differences between the LMWH preparations that may result in different clinical outcomes, and also reviews the implications and challenges physicians face when generic versions of the original/innovator agents are approved for clinical use.

Notices of judgment under the Food and drugs act.

Nos. 2986-15000, Aug. 3, 1914-June, 1927, issued as Supplements to Service and regulatory announcements of the Bureau of chemistry. Beginning with no. 3501, Apr. 3, 1915, Supplements are numbered consecutively S.R.A. Chem. suppl. 1-230.

The regulation of pesticides in the United States /

Cover title.

Parathion data presented to U.S. Food and Drug Administration, in the matter of: tolerances for poisonous or deleterious residues on or in fresh fruits and vegetables.

Cover-title.

FDA consumer nutrition knowledge survey : a nationwide study of food shopper's knowledge, beliefs, attitudes, and reported behavior regarding food and nutrition /

Includes bibliographical references.

FDA drug bulletin April 1970 through October 1990 ; FDA medical bulletin March 1991 through June 1993 : index by subject and title.

Mode of access: Internet.

Pesticide chemicals: regulations under the Federal food, drug, and cosmetic act.

Kept up-to-date by revised pages which are inserted.