The FDA is expanding and clarifying its standards for companies looking to hash out clinical research plans with the agency.
In a draft guidance issued last week, the FDA revisits a 14-year-old document on special protocol assessments (SPA) for determining trial standards on investigational new drugs. The document vastly expands on its previous incarnation by setting submission requirements for: drug substance and drug product stability protocols, animal testing efficacy protocols and clinical trial protocols.
For clinical trial protocols designed for efficacy claims or to demonstrate biosimilarity, the FDA wants to ensure they supply essential data elements for adequate and well-controlled trials. If protocols contain data from only one clinical trial, the FDA recommends the sponsor reference the guidance on providing clinical evidence of effectiveness for human drug and biological products to gain insight on protocol design.