Blog
Study reveals correlation between number of patients and phase of oncology clinical trials
A recent study, “Oncology Clinical Trials: Drug Development and Case Studies” examined the average number of patients per site during different phases of oncology trials. The study found that Phase 1 trials averaged 12.9 patients per site, while Phase 2 and Phase...
Proposed US government funding may increase FDA oversight in China
The continuing resolution (CR) bill provides the FDA with an increase of $24 million is the 2013 fiscal year, according to a recent article on outsourcing-pharma.com. The proposed $2.5 billion FDA budget includes $10 million that would allow FDA to add 16 inspectors...
FDA final Rule Rejects Parental Waivers and Final Document
At the end of February, FDA released a final rule, entitled “Additional Safeguards for Children in Clinical Investigations of Food and Drug Administrated-Regulated Products.” The final rule says that FDA will not allow waivers of parental or guardian permission for...
Sequester hits hard at FDA
The government’s imposed sequester is set to reduce FDA’s budget by $209 million between now and September 2014, as cited in a recent article on in-pharmatechnologist.com. With the strict budget cuts, the FDA plans to deal with the most relevant objectives. FDA does...
Save the Date: June 12, 2013, St. Vincent Health Research Symposium
St. Vincent Health is hosting its annual research symposium with breakout topics to include regulatory affairs, women's health and family medicine. What: St. Vincent's 9th Annual Research Symposium When: June 12, 2013 Time: 7:15am- 4:45pm Where: Lily Conference Center...