Last week, FDA released draft guidance entitled, “Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease,” which addresses the FDA’s view regarding the selection of patients with early Alzheimer’s Disease (AD), or at risk patients for clinical trial enrollment. According to a recent article on outsoucingpharma.com, the more flexible regulations provide more treatment opportunities for patients and create for a potentially easier path for CROs. To read the complete draft guidance, click here. To read the full article on outsourcing-pharma.com, click here. For help with clinical trials contact us at 317-899-9341.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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