Wyeth's ReFacto Promotion Cited By FDA For Undemonstrated Safety Claims
This article was originally published in The Pink Sheet Daily
ReFacto brochure claims "albumin-free final formulation for unsurpassed viral safety." Wyeth has pulled the cited material from the market.
You may also be interested in...
FDA’s draft guidance on systemic lupus erythematosus drug development lists four possible claims that the agency “may be willing to approve”: reduction in disease activity; organ-specific lupus treatment; complete clinical response/remission; and reduction in flares.
Three FDA risk management final guidances recommend that sponsors collect a wide range of safety data during both the clinical trial and postmarketing periods of drug development. The agency suggests that sponsors hold discussions with FDA before settling on drug study designs or postmarketing activities.
FDA is planning to develop a Risk Minimization Action Plan website, an agency risk management guidance states