Thursday, September 3, 2015
FDA Draft Guidance on Male-Mediated Developmental Risks for Pharmaceuticals
The ClinicalTrials.gov registry, which was introduced in 2000, appears to have had a noticeable impact on the number of reported positive and negative effects of heart disease treatments before and after that year, according to a recent PLoS ONE study.
People who delay or refuse vaccines for themselves or their children are presenting a growing challenge for countries seeking to close the immunization gap. Globally, one in five children still do not receive routine life-saving immunizations, and an estimated 1.5 million children still die each year of diseases that could be prevented by vaccines that already exist, according to the World Health Organization (WHO).
China has decided to reform its appraisal and approval system for drugs and medical instruments with the aim of improving drug safety and quality and encouraging innovation.
Mylan has been sued by BTG International, Janssen Biotech, Janssen Oncology and Janssen R&D in connection with the filing of an Abbreviated New Drug Application (ANDA) with the FDA for Abiraterone Acetate Tablets, 250mg. This product is the generic version of Zytiga, which is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.
With declining federal research budgets, those who typically raise money from outside sources to pay for clinical research have an alternative: Charge patients to participate in clinical trials that typically would not get funded.