A surge in applications to test and develop new cellular and gene therapies is overwhelming staff at FDA s Center for Biologics Evaluation and Research (CBER) and prompting calls from manufacturers and research organizations to increase funding for these programs. At the public meeting to… Read More »Stakeholders Seek Increased User Fee Support for Biologics
As the world waits anxiously for more effective COVID-19 treatments and for a vaccine to halt the pandemic, analysts on all sides are examining appropriate pricing models for these critical products. Gilead s $3000 price tag on remdesivir ($2300 for US public health programs), set… Read More »Drug Pricing Back in the Spotlight
FDA announced in July that it plans to resume inspections of some US-regulated facilities this week, but it s not clear how it will decide which sites to visit and what alternative oversight strategies will apply where on-site inspections are difficult. Yet, the resurgence in… Read More »Will FDA Inspections Ever Be the Same?
With more than 100 vaccine research programs looking to address the pandemic, FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives. The agency recently issued a lengthy guidance outlining recommendations for documenting vaccine quality,