CBER publishes a Standard Operating Policy and Procedure resource on complying with provisions of the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.
Four stakeholders recommend ways FDA can improve a draft guidance on leveraging prior knowledge in developing some human gene therapy products.
CBER publishes a Standard Operating Policy and Procedure resource on complying with provisions of the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.
Four stakeholders recommend ways FDA can improve a draft guidance on leveraging prior knowledge in developing some human gene therapy products.
FDA warns India’s Shoolin Pharma Chem that it is producing active pharmaceutical ingredients in insanitary conditions and with significant CGMP deviations.
FDA orders a Boxed Warning for American Regent’s Injectafer (ferric carboxymaltose injection) over the risk of symptomatic hypophosphatemia.
