“The Alzheimer’s Plan”: CFS/ME Patients Seek “Loosening” Of Approval Requirements
FDA’s recent guidance on drug development in early-stage Alzheimer’s did not change the standard of evidence required for approval, agency official says amid calls to ease requirements for chronic fatigue syndrome/myalgic encephalomyelitis.
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The two-day workshop on chronic fatigue syndrome/myalgic encephalomyelitis elicited extensive, detailed testimony from patients about their symptoms and current treatment that will inform FDA policy, but it also underscored the challenges of explaining FDA’s regulatory processes to the patient community.
A draft guidance for development of drugs to treat early Alzheimer’s disease does not loosen agency standards, FDA’s neurology products chief asserts. Rather, it is an attempt to establish criteria tailored to the population.
FDA’s new draft guidance on developing drugs to treat people in the early stages of Alzheimer’s disease, before any noticeable dementia sets in, is sure to generate further discussion and comment on how best to identify and measure the disease and its progression.