Regulatory Affairs

Hamburg: Global Regulatory Authority in the Works

To help improve drug safety and quality, the FDA and other countries’ drug industry regulators are considering forming a global authority dubbed the International Coalition of Medical Regulatory Authorities, Commissioner Margaret Hamburg says. Read More

Safety Concerns Set Back Another Halozyme Mid-Stage Trial

Halozyme has temporarily halted another trial due to safety concerns. This time, the drugmaker decided to hit the brakes after patients treated with PEGPH20, a pegylated form of its anti-cancer enzyme rHuPH20, showed increased risk for certain blood clots. Read More