This report evaluates environmental stressors to coral in the Florida Reef Tract with a focus on the Florida Keys through the lens of accepted global and local factors.
Comments regarding guidance for clinical investigators, sponsors, and institutional review boards on investigational new drug applications - Determining whether human research studies can be conducted without an investigational new drug application.
This report builds upon current insights with findings from a new survey which examines two important stakeholder groups and analyzes what drives these groups’ use and trust in OTC medicines.
Letter regarding FDA draft guidance entitled “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application.” These comments are focused on issues related to dietary supplements as referenced in the draft guidance.
CHPA comments on the “Notice of Availability of Draft Guidance Regarding Which Children’s Products are Subject to the Requirements of CPSIA Section 108.”