FDA sends Sobi Inc. an untitled letter that cites a direct-to-consumer television advertisement for its myelofibrosis drug Vonjo (pacritinib) because it misbrands the product.
Human Drugs
Commissioner’s Voucher Program Q&A Published
FDA moves to blunt criticism of the Commissioner’s National Priority Voucher Program with a news release containing 18 questions and answers, making the point that all voucher drug approvals are made by the agency review staff and not by a select group operating independently under the voucher program.
