Fisons
Executive Summary
Six top-ranking execs visit FDA June 22 to discuss the company's "future direction" with Deputy Commissioner for Operations Jane Henney, MD, CDER Director Carl Peck, MD, General Counsel Margaret Porter, and others. Fisons execs attending included Pharmaceutical Chairman and company CEO Cedric Scroggs. The British-based company's Opticrom cromolyn sodium anti-allergy eye drops and Imferon injectable iron continue to be unavailable in the U.S. due to regulatory problems at Fisons' Holmes Chapel, U.K. facility. FDA made its fourth inspection visit in two years to Holmes Chapel in April to review Opticrom manufacturing practices ("The Pink Sheet" May 11, T&G-13).
You may also be interested in...
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
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: