Tracking Drug Manufacturing Plant Inspection Reports Online

Health Canada has put all Drug Establishment License (DEL) holders on alert as to their regulatory responsibilities and obligations for maintaining good manufacturing practices (GMP).  In addition to increasing the frequency of planned and unplanned inspections of...

CDER Guidances for Nonclinical Toxicology to Issue in 2012

The FDA has published an updated Guidance Agenda – new and revised draft guidances CDER is planning to publish during calendar year 2012.   Guidances of particular interest to nonclinical pharmaceutical toxicologists may include: Pharmacology/Toxicology •...

FDA New Drug Reviews: Past and Future Perspectives

Analysis and overview of new drug reviews from 1993 through present by an over 20-year-active FDA veteran of drug approvals, Dr. John Jenkins (Director, Office of New Drugs, Center for Drug Evaluation and Research).  The presentation includes review times and...

FDA Pharamacogenomic Biomarker Database

Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labels may contain information on genomic biomarkers and can describe: Drug exposure and clinical response...

FDA Resource for Approved Drug Information

Ever wanted to know the ins and outs of almost every drug approved by the Food and Drug Administration since 1939? By using the Drugs@FDA database, you can search for information about FDA-approved brand name and generic drugs and therapeutic biological products.  The...

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

Both pharmaceutical industry and regulatory professionals acknowledge the importance of balancing timely access to new medicines with the need for thorough review of drug safety and efficacy data.  A new study, funded by the Pew Charitable Trusts (to be published in...