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Meta
Tag Archives: FDA Guidance
Biosimilars Ahead, Proceed with Caution
By Richard M. Dolinar, M.D., Chairman, Alliance for Safe Biologic Medicines In today’s budget-constrained world, the goal for health care is not only to save lives but also to save money. On Friday, May 11, the Food and Drug Administration (FDA) will hold a one-day public hearing on important medicines, known as biosimilars, that are under FDA consideration to come to the United States (U.S.) and offer the opportunity to help achieve the second prong Read More >
Getting the Guidance We Need: FDA Finalizes Regulatory Guidance for GE Animals
Well, it’s finally happened. The FDA announced today that it will make the final guidance available for governing genetically engineered animals. And if I strain carefully, I can already hear them — the naysayers. For example, back in November, the Consumers Union, the nonprofit publisher of Consumer Reports, submitted comments to the FDA containing the following statement, “A major problem with this proposal is that it is simply Guidance for Industry and so is not Read More >
