WASHINGTON - Probably the most significant aspect for the biotechnology industry of the two draft guidances released last week as part of FDA's "New Use Initiative" was a clear description of the circumstances under which the agency will accept a single, well-controlled study as evidence of safety and efficacy of a new therapy

As FDA notes in the documentation (see BioCentury Extra, March 14), it has accepted data from a single trial in the past, but the lack of a clear explication of when a single trial is sufficient has made it difficult for companies to plan product development. Although FDA did not mention it, the document may be helpful in educating its advisory committees, which often do not spend as much time studying changes in regulatory requirements as do sponsors or FDA officials.