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In the latest move in a multi-year wrangle between the FDA and Vanda Pharmaceuticals over the agency’s proposed refusal to approve a supplemental new drug application (sNDA) for Hetlioz (tasimelteon) as a treatment for jet lag, the FDA is offering Vanda a hearing — but only under specified conditions. Read More
The FDA wants to remove Covis Pharmaceuticals’ preterm birth drug Makena (hydroxyprogesterone caproate) from the market, contending that 11 years of postmarket data have failed to show Makena actually does what Covis claims — improve neonatal outcomes in premature births. Read More
Congress may have delayed reauthorization of the FDA’s user fee programs until almost the last hour, but the agency had its table of rates worked out and queued up for publication within the week. Read More
The biggest insulin producers — Eli Lilly, Novo Nordisk and Sanofi — are falling short in their efforts to expand global access to the life-saving drug, claims a new report from the Access to Medicine Foundation, a nonprofit group. Read More
Abbreviated new drug application (ANDA) applicants may request a meeting to discuss problems identified in a complete response letter (CRL), according to a final guidance that explains what should be discussed — and not discussed — during the meeting. Read More
Since Congress reauthorized the FDA’s generic drug user fee program last Friday, the FDA has published multiple related guidances and other official instructions and directives each day. Read More
A bipartisan bill just introduced in the U.S. House of Representatives seeks to abolish reimbursement restrictions placed on antiamyloid antibodies as a treatment for Alzheimer’s disease. Read More