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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
The drug also received Fast Track status for the treatment of patients with first-line recurrent or metastatic head and neck squamous cell carcinoma. Read More
As part of its commitments under the newly reauthorized Prescription Drug User Fee Act (PDUFA VII), the FDA has launched the Rare Disease Endpoint Advancement (RDEA) pilot that will test a new meeting system to help sponsors of rare disease clinical trials develop efficacy endpoints. Read More