Issue Date: April 4, 2014
Issued by: Center for Veterinary Medicine
Topic(s): Records
Status: Final
Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act
This guidance document provides updated information pertaining to the Food and Drug Administration’s (FDA) authority to access and copy records under sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance is a revision of FDA’s November 2005 guidance entitled “Guidance for Industry and FDA Staff: Guidance for records access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Final Guidance.” FDA’s staff manuals, the Regulatory Procedures Manual (RPM) and Investigations Operations Manual (IOM), contain operational and procedural steps for FDA staff to follow for accessing records under sections 414 and 704 of the FD&C Act; therefore, that information has been removed from this guidance. Both the RPM and IOM are located on FDA’s website, www.fda.gov . FDA’s guidance documents, including this guidance, 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. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Download the Guidance Document
