As reporter in BioCentury, HHS will appoint Elizabeth Dickinson as acting FDA chief counsel, effective Aug. 8, according to an internal memo from acting HHS General Counsel William Schultz. Dickinson, who has been at FDA's Office of Chief Counsel since 1994, will replace Ralph Tyler, who is departing. The memo noted that HHS plans to convert the chief counsel position into a career job; currently, it is filled via political appointment.
And on a more therapeutically personalized note, FDA released draft guidance on the development of in vitro companion diagnostics. The document clarifies FDA's definition of a companion diagnostic, reiterates the agency's intention to conduct simultaneous reviews of a product with its companion diagnostic, and identifies situations where the agency may approve a targeted product in the absence of an approved companion diagnostic. However, the guidance does not address the design or conduct of clinical trials of products in combination with companion diagnostics.
FDA defines a companion diagnostic as a device that provides information essential for the safe and effective use of a corresponding therapeutic. The agency added that the definition does not include clinical laboratory tests intended to provide "useful" information where that information is not a determining factor in the safe and effective use of a therapeutic.
The guidance notes that product labeling should only identify a type of approved companion diagnostic device, rather than a specific manufacturer's device. FDA said this will facilitate the development and use of more than one approved diagnostic of the type described in the companion product's label. Comments are due 60 days after publication in the Federal Register, which is expected Thursday.
