FDA Update
FDA May Nix The "Not Approvable" Letter
Kate Fodor | Sep 12, 2004
Under a new proposal, the Food & Drug Administration may stop issuing "approvable" and "not approvable" letters to drug sponsors whose applications need to be revised or amended. Instead, companies would receive a "complete response" letter similar to those already used by the FDA for biologics. Using the same name for all the letters should help clear up some of the confusion that can be caused by the current system, according to John K. Jenkins, who heads the Office of New Drugs in the FDA
More Compounds Failing Phase I
Anne Harding | Sep 12, 2004
More drugs in development are failing to make it to market, according to Acting FDA Commissioner Lester M. Crawford. Historically, 14% of drugs entering Phase I have won approval, Crawford said in a speech to the Banc of America Securities Healthcare Institutional Conference on July 7, but now only 8% reach the marketplace. One-half fail in Phase III, he added, compared to one in five in the past. This has pushed the cost of developing a drug from $1.1 billion in 1995 to $1.7 billion in 2002, he
New Cancer Office in the Works
Kate Fodor | Sep 12, 2004
Paul Richardson© 2004 ASCO/Todd BuchanonThe FDA is consolidating several divisions into a single Office of Oncology Drug Products (ODP) that will oversee drugs and certain therapeutic biologics targeted at cancer, as well as drugs and biologics for medical imaging. The office, which should be fully operational by April 2005, will be housed in the Center for Drug Evaluation and Research (CDER). The ODP will have three review divisions, but exactly how staff, products, and responsibilities wi