dose to dose is a commonly encountered expectation when a drug or device is billed as one affording the user "control" over or against a condition.6


39
The Commission's further ruling that Cyanamid's efficacy data must include two well-controlled studies, and that one of them must be a field study, derives from the express terms of 21 U.S.C. Sec. 360b(d)(3) ("well-controlled investigations, including field investigation....").  The Commissioner found that Cyanamid failed to submit a well-controlled field study.


40
Cyanamid now asserts that the word "field" in Sec. 360b(d)(3) is so fraught with ambiguity as to be meaningless.  The petitioner's earlier actions belie its argument.  Cyanamid had labeled two studies it submitted to the FDA "field investigations."    Commissioner's Decision at 130.  Before the Commissioner, Cyanamid stated that it understood the term to mean "a study evaluating products under actual conditions of use."    Id. (quoting Cyanamid's memorandum in support of its exceptions to the Initial Decision).  Evaluation conducted in situations approximating the actual conditions of use is the definition of "field investigation" employed by the FDA, and was the definition once comprehended by Cyanamid.  We accept the FDA's definition as a reasonable interpretation of Sec. 360b(d)(3) and we uphold the Commissioner's conclusion that Cyanamid did not submit the statutorily required "well-controlled ... field investigation."   See also United States v. An Article of Drug Consisting of 4,680 Pails, 725 F.2d 976, 987 (5th Cir.1984) ("[T]he very definition of substantial evidence in the Act requires that field investigations be included;  an in vitro study is not a field investigation.").


41
In addition to the shortfall on continuous control and the absence of a well-controlled field study, the Commissioner found several Cyanamid submissions fatally defective because they tested Proban's active ingredient, cythioate, instead of the product's market formulation, including its inert ingredients.  The Com