Anthra Bonefos advisory committee
Executive Summary
Anthra's Bonefos (clodronate sodium) will be reviewed by FDA's Oncologic Drugs Advisory Committee on the afternoon of Dec. 4. Anthra is seeking approval for the bisphosphonate (NDA 21-326) in the reduction of skeletal complications of bone metastases in patients with breast cancer. The meeting will be held at the Holiday Inn in Silver Spring, Md. The oncology committee will consider Guilford's NDA (20-637/S-016) for Gliadel Wafer (polifeprosan 20/carmustine implant) for first-line malignant glioma in the morning (1"The Pink Sheet" Oct. 15, In Brief)
You may also be interested in...
Gliadel Wafer advisory committee
Guilford's Gliadel Wafer will be reviewed by the Oncologic Drugs Advisory Committee on Dec. 4 for treatment of first-line malignant glioma. The ODAC panel was originally scheduled for the afternoon of Sept. 11, but was cancelled due to the terrorist attacks. The meeting will begin at 8 a.m. at the Holiday Inn in Bethesda, Md
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials