Blog
FDA Public Hearing April 23-24, 2012
The FDA will hold a 2 day public hearing to obtain input from those interested in FDA's scope and direction in modernizing regulations, policies, and practices that apply to clinical trials of FDA-regulated products. Anyone interested is strongly encouraged to join...
New FDA Informed Consent Requirements
In February, FDA released a new guidance document entitled “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)”. The purpose of the guidance is to help small businesses, particularly clinical trial sponsors, investigators, and institutional review...
Are clinical trial patients doing more harm than good?
Several sources have recently pointed to possible links between poor patient adherence during clinical drug trials and unexpected adverse effects—as well as personal injury cases—once the drug is approved and marketed. Chief among these sources is the Consumer Health...
IOM report highlights benefits of pediatric drug studies
A report released Feb. 29th by the Institute of Medicine (IOM) provided a review of the benefits of current federal laws that offer incentives for or require drug and biologic developers to conduct pediatric studies. The report also highlighted several areas where...
Late Payments Stalling Clinical Trials
Check out what our friend and colleague Christine Pierre had to say in this February 21, 2012 article by Ann Neuer of bioitworld.com. Christine gave her thoughts on the current budget woes that exist within the clinical trial process. As she shares, budgets are...