New Agency to Soon Replace French AFSSAPS
France has created a new agency, the National Agency for the Safety of Medicines and Health Products (MSNA), to replace its current regulatory agency, Afssaps.
The move was announced April 29 in France's Official Journal, which noted the new agency remains under development and the change will be effective in a few months.
MSNA will have a broader regulatory authority for monitoring and evaluation of health products, such as the development of independent research on product safety and requiring clinical studies against active comparators and placebo, Afssaps said in a statement.
The new agency will also have an operating budget greater than Afssaps (157 milliion Euros in 2012 vs. 125 million in 2010) and is financed exclusively by a state subsidy rather than through taxes or user fees from manufacturers.
Afssaps has been reeling from a series of scandals in recent months, including reports that the anti-diabetes drug Mediator was left on the market for a decade longer than was safe and its failure to stop defective breast implants manufactured by Poly Implant Prothese from being implanted into thousands of patients in France.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
