CDER Compliance Office's Gray Retiring; ORA Advisor To Be Acting Director

FDA Office of Regulatory Affairs Senior Advisor John Taylor will provide interim leadership to the Center of Drug Evaluation & Research's Compliance Office beginning April 18.

Taylor will hold the acting director position for a three-month detail. Office of Compliance Deputy Director Betty Jones will serve as acting director until April 17.

Taylor will succeed Office of Compliance Director Stephanie Gray, who is retiring from FDA April 22.

Gray will spend her remaining time at the agency on a detail assignment assisting in CDER's international operations. CDER's international activities were managed by Roger Williams, MD, prior to his departure from the agency to head U.S. Pharmacopeia (¹ (Also see "CDER Deputy Director Williams Leaving FDA To Head U.S. Pharmacopeia" - Pink Sheet, 11 Oct, 1999.) .

Gray has been involved in negotiating the Mutual Recognition Agreement and has participated in the International Conference on Harmonization.

Under Gray's leadership, the office made progress in establishing MRA and ICH, as well as the formation of an establishment inspection report, a mutual recall and safety alert system and good inspection practices.

Gray served on the foreign inspections working group set up by former FDA Commissioner David Kessler, MD, which preceded the formation of MRA and ICH.

Gray guided the office through the 1997 introduction of the Field Accomplishments and Compliance Tracking Systems and the system's integration with the agency's automated import clearance system.

Another compliance initiative under Gray was the first-party audit program proposed in 1997, although it has not been well received by the industry.

The compliance office also initiated efforts to link drug sponsors and problematic clinical investigators during Gray's directorship.

Gray's tenure with the Office of Compliance began in 1993, when she joined CDER from the San Juan, Puerto Rico district office.