ToxInsights | TigerTox

Tracking Drug Manufacturing Plant Inspection Reports Online

by cdavenport | Drug Safety, Health Canada, Pharmaceutical Manufacturing, Regulatory

Health Canada is increasing inspection frequency and offers a new online tool for tracking regulatory actions against drug manufacturing companies.

Brain Maps: Live 3D Imaging of Activity

by cdavenport | Central nervous system, Drug Safety, Preclinical, Risk Management, Techniques, Toxicology

Light-field laser generates 3D movie of entire brain to create a “living” brain map.

Postmarket Surveillance: Ethics Cited as Critical Weakness

by cdavenport | Drug Safety, FDA, Postmarket Surveillance, Risk Management

Increased “fast-tracking” of drug approvals necessitates a counterbalance of enhanced postmarket surveillance and ethical governance throughout the lifecycle of a drug.

CDER Guidances for Nonclinical Toxicology to Issue in 2012

by cdavenport | ADME, Drug Safety, FDA, Preclinical, Regulatory, Toxicology

CDER guidances of particular interest to nonclinical pharmaceutical toxicologists are slated to issue in 2012.

Off-label Drug Use: Fact vs. Fiction

by cdavenport | Drug Promotion, Drug Safety, FDA

This article offers a concise review of the topic of off-label drug use including its definition, prevalence, and implications for drug safety.

FDA Uses Linguamatics to Increase Drug Safety

by cdavenport | Drug Safety, FDA, Linguamatics, Postmarket Surveillance

CDER will use natural language processing to mine published literature to address issues relevant to drug safety.

Assessing Safety Earlier in Drug Development

by cdavenport | Biomarker, Drug Safety, Preclinical, Risk Management

A recent survey identified trends in safety biomarkers and their utilization in drug development.

New Procedure Cage Reduces Primate stress

by cdavenport | Caging, Techniques, Toxicology

New procedure cage attaches directly to an animal’s home cage and eliminates hand capture or use of other restraints, creating calmer handling environment.

FDA New Drug Reviews: Past and Future Perspectives

by cdavenport | Drug Safety, FDA, Pharmaceutical Business, Regulatory

This slide presentation gives excellent perspective of past and future trends for the global pharmaceutical market, with emphasis on FDA approvals of NME.

FDA Pharamacogenomic Biomarker Database

by cdavenport | Databases, Drug Safety, FDA, Genetic Toxicology, Regulatory

A resource table listing FDA-approved drugs with pharmacogenomic information / biomarkers in their labels.

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