The FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research adopted final guidance on the harmonization of manufacturing processes for new drug substances and products, including steps designed to reduce impurities.

The nonbinding recommendations concluded that manufacturing process development should include, at a minimum, the following elements:

• identifying potential critical quality attributes (CQA) – properties or characteristics that affect identity, purity, biological activity and stability – associated with the substance so those characteristics having an impact on drug product quality can be studied and controlled;

• defining an appropriate manufacturing process;

• defining a control strategy to ensure process performance and drug substance quality.

An enhanced approach to manufacturing process development also would include a systematic approach to evaluate, understand and refine the manufacturing process through identification (e.g., prior knowledge, experimentation and risk assessment) of the material attributes (e.g., raw materials, starting materials, reagents, solvents, process aids and intermediates) and process parameters that can affect drug substance CQAs and determination of the functional relationships that link material attributes and process parameters to drug substance CQAs.

The increased knowledge and understanding gained from an enhanced approach could facilitate continual improvement and innovation throughout a product's life cycle, the agencies concluded.

The guidance (1.usa.gov/UDn7dD), which also explains how to submit manufacturing process development information, is scheduled to be published in the Federal Register.

Comments Sought on Therapeutic Standards

The FDA is seeking to prioritize and develop therapeutic area data standards to facilitate the conduct of clinical research and the regulatory review of medical products, with the goal of enhancing the agency's ability to integrate, analyze, report and share regulatory information. The FDA has developed a roadmap that provides its current thinking on therapeutic area priorities, which is posted on the FDA website (1.usa.gov/Ub0Ebz).

Under section XII of the Prescription Drug User Fee Act V performance goals, the FDA also agreed to create a plan for distinct therapeutic area data standards and to prioritize and develop the data standards in collaboration with industry, the Clinical Data Interchange Standards Consortium, the Critical Path Institute, Health Level 7's Clinical Interoperability Council and other organizations. The agency is seeking public comment on the roadmap as it develops its proposed project plan, which is due to be issued for review and comment by June 30, 2013.

The request for comments (1.usa.gov/XtHOAo) is scheduled to be published in the Federal Register.

Using Electronic Data in Clinical Trials

The FDA also is requesting comments on a revised draft guidance on the use of electronic source data in clinical trials. The document is designed to help sponsors, contract research organizations, data management centers, clinical investigators and others involved in capturing, reviewing and archiving electronic source data in FDA-regulated clinical trials to ensure the reliability, quality, integrity and traceability of the data.

The draft guidance discusses:

• identifying and specifying authorized source data originators;

• creating data element identifiers to facilitate authorized parties to examine the data audit trail;

• capturing source data into electronic case report forms.

The draft guidance (1.usa.gov/XWILQJ), which also outlines investigator responsibilities in reviewing and retaining electronic data, is scheduled to be published in the Federal Register.