Four FDA senior officials explain how the agency is strengthening its good clinical practice oversight in an increasingly globalized clinical trial environment.
FDA publishes a request for information on stakeholders’ views on ways to accelerate botanical drug development.
Four FDA senior officials explain how the agency is strengthening its good clinical practice oversight in an increasingly globalized clinical trial environment.
FDA publishes a request for information on stakeholders’ views on ways to accelerate botanical drug development.
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Four stakeholders recommend ways FDA can improve a draft guidance on leveraging prior knowledge in developing some human gene therapy products.
