Just released from FDAnews — Investigations Operations Manual 2014 — the FDA’s own internal guidance on how to inspect a drug or device company. Know what the investigators look for — before they even get there.
The Austrian company AFFiRiS A.G. of Vienna said this week it has begun the first-ever clinical trials of a vaccine to treat Parkinson’s disease. The study of as many as 32 patients is designed to test the safety and tolerability of the vaccine, called PD01A. Los Angeles Times