Bergeson & Campbell, P.C. news
On May 19, 2014, the European Commission (EC) Joint Research Center (JRC) announced the availability of a report discussing labeling and reporting schemes for nanomaterials in consumer products in the European Union (EU). The JRC notes that current EU legislation requires nanomaterials to be reported in the list of ingredients, with “nano” added in brackets after the substance name, for fo
On May 12, 2020, the U.S. Food and Drug Administration (FDA) announced the release of an update to its Purple Book: Database of FDA-Licensed Biological Products (Purple Book). The update adds all FDA-licensed biological products, including products approved in the new drug applications (NDAs) that were
On August 3, 2017, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing revised comment period dates for the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) meeting regarding the “Continuing Development of Alternative High-Throughput Screens to Determine Endocrine Disruption, Focusing on Androgen Receptor, Steroidogenesi
On April 6, 2020, the U.S. Food and Drug Administration (FDA) published a report that provides options and recommendations for a new methodology to evaluate changes in resource capacity needs of human drug and biosimilar biologic review programs. Titled “Independent Evaluation of the PDUFA and BsUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations,” the analysis of t