Like It Or Not, FDA Is At The Center Of Drug Pricing Debate
This article was originally published in The Pink Sheet Daily
House committees create demanding schedule for CDER's Woodcock, requiring her at two hearings 90 minutes apart.
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Agency plans to issue 102 new and revised draft guidances this year, including those on use of multiple endpoints in clinical trials, 180-day exclusivity, and ANDA refuse-to-receive standards.
Group of 11 companies is focusing on biosimilar reimbursement and educational issues important to market formation.
Congress should give FDA more flexibility to administer orphan designations, such as the ability to revoke designations later if the disease prevalence grows beyond the rare disease threshold.