The FDA recently issued two new Guidance for Industry documents, both related to the approval process for new animal drugs.
Guidance for Industry 227 provides recommendations for a two-phased process drug sponsors could use to submit chemistry, manufacturing, and controls (CMC) data to the agency. The guidance finalizes a draft that was first issued in October 2014.
According to the guidance, the FDA’s Center for Veterinary Medicine (CVM) prefers that CMC information be submitted in a single technical section for review efficiency. However, there may be instances when a two-phased technical submission process is more beneficial to improve the overall time to drug approval. Sponsors may submit the phased CMC technical section as a single technical section or a two-phased technical section. Guidance 227 describes the use of the two-phased technical section submission process and also walks sponsors through the process for both submission phases.
Guidance for Industry 225 intends to help standardize for global exchange the format of electronic veterinary medical product records. The guidance recommends electronic file format specifications for individual documents and collections of multiple related documents for electronic exchange between industry and regulators in the context of regulatory approval of veterinary medicinal products. This guidance document finalizes a draft that was issued in August 2014.
The guidance applies to electronic files related to applications for initial marketing authorizations, related pre-submission or post-authorization procedures, applications for maximum residue limits, clinical trial applications, drug / active substance master files or requests for regulatory or scientific advice.
According to the document, the electronic exchange of regulatory documents concerning veterinary medicinal products between industry and regulatory authorities is commonplace. Global harmonization of the specifications for the electronic file format of documents is seen as a fundamental starting point to realizing the potential benefits.
FDA notes that these guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.