What is the best way to encourage drug development in an unmet medical need? Chronic Fatigue Syndrome advocates argue that FDA should approve a drug—specifically Ampligen—even if it falls far short of reaching typical standards of evidence. FDA disagrees, and gained the backing of its advisory committee on that point. But the vote was close…
It is hard to describe the Arthritis Advisory Committee’s December 20 rejection of Hemispherx Biopharma Inc.‘s Ampligen for Chronic Fatigue Syndrome as in any way surprising.
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PhRMA questioned whether proof-of-concept studies are needed before an INTERACT meeting and said a draft guidance describing the timing of definitive toxicology studies creates confusion.
The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.
Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.
