RE: Review of Existing Center for Drug Evaluation and Research Regulatory and Information
Collection Requirements
Dear Dr. Gottlieb,
The Alliance of Specialty Medicine (the “Alliance”) represents more than 100,000 specialty
physicians from thirteen specialty and subspecialty societies. The Alliance is deeply committed
to improving access to specialty medical care through the advancement of sound health policy.
The undersigned members of the Alliance appreciate the opportunity to provide feedback to
the agency as it works to identify existing regulations and related paperwork requirements that
could be modified, repealed, or replaced, consistent with the law, to achieve meaningful
burden reduction while allowing FDA to achieve its public health mission and fulfill statutory
obligations. Specifically, we have concerns about draft and final guidance documents issued by
the agency, as well as delayed final rules related to “intended uses,” which we discuss in detail
below.
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