ToxInsights | TigerTox

PDUFA V: Risk – Benefit Emphasis New

by cdavenport | Drug Safety, FDA, Risk Management

In examining drug safety, the PDUFA V legislation places new emphasis on the risk vs. benefit of new drugs.

FDA Resource for Approved Drug Information

by cdavenport | Databases, FDA, Preclinical, Regulatory

Ever wanted to know the ins and outs of almost every drug approved by the Food and Drug Administration since 1939?

New Hypersensitivity Screen for Drugs

by cdavenport | Drug Safety, Immunogenicity, Preclinical, toxicity, Toxicology

Researchers find new way to screen drugs for adverse hypersensitivity reactions before use.

Preclinical Safety Testing: Use of Transgenic Animals

by cdavenport | Carcinogenicity, Drug Safety, Preclinical, Species Selection, Techniques

Transgenic and genetically modified animal models are increasingly being used in the study of disease and for the safety assessment of new compounds.

Sexual maturity in primates: new challenges for drug safety evaluation

by cdavenport | Caging, developmental and reproductive, Drug Safety, enrichment, Preclinical, species, Species Selection, Techniques, Toxicology

Use of sexually mature primates in toxicology is providing new opportunities and challenges.

Drug Safety: Tip of the Iceberg

by cdavenport | Drug Safety, FDA, Post-market Surveillance, Risk Management, toxicity

The 10 drugs with the largest number of adverse event reports sent directly to the FDA in 2011 are detailed.

US, Canada, and EU – Who wins the Drug Approval Race?

by cdavenport | Drug Safety, Preclinical, Regulatory

The US FDA leads its EU and Canadian regulatory counterparts in approving more novel drug applications faster over the last decade.

Potential Academic Contributions to Drug Development

by cdavenport | Drug Safety, FDA, Techniques

The FDA encourages academic researchers to drive changes in the required testing paradigms (nonclinical and clinical) to enable faster, better, and cheaper drug approvals.

Drug Safety: IOM Pharmacovigilance Report

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

An Institute of Medicine (IOM) committee report makes pharmacovigilance recommendations and favors centralization of drug safety data.

Preclinical Offshoring Anticipated to Continue: Survey

by cdavenport | Drug Safety, Pharmaceutical Business, Toxicology

Preclinical offshoring is anticipated to continue for 2-5 years for early Discovery and non-GLP Toxicology studies, despite narrowing price differentials.

BLOG