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New Combination Products Regulation Coming This Year, or Not

FDA's work on regulations and guidances specific to combination products has advanced very slowly, and recent turnover at the Office of Combination Products hasn't helped, reports a consultant who keeps close tabs on the OCP.

Transforming FDA LogoFDA's work on regulations and guidances specific to combination products has advanced very slowly, and recent turnover at the Office of Combination Products hasn't helped, reports a consultant who keeps close tabs on the OCP. Michael Gross, prinicpal consultant of Chimera Consulting and a member of the Combination Products Coalition, said OCP told him that a regulation regarding quality systems for combination products will come out this year. He spoke at the PharmaMedDevice conference in Philadelphia yesterday. Such a regulation is important because it is not clear when firms should follow quality-system practices for devices and when they should follow the ones for drugs. However, Gross said, the OCP once said it would come out in 2007, so nothing about the timetable should be taken for granted. Similarly, he said, OCP has said it will publish a guidance on safety reporting this year, but when it will actually appear is anyone's guess. OCP had four directors last year: Mark Kramer, who left in April after more than five years in the post; Joanne Less, who left in October; Patricia Love, who served as acting director from October to December, and Thinh Nguyen, who took over in December. It also lost Jim Cohen, an attorney who was instrumental in drafting its regulations and guidances, and Suzanne O'Shea, its product jurisdiction officer. This turnover is exacerbating the slowness of progress, Gross said.
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