Cassandra Taylor and Schuyler Pruyn of the Center for Drug Evaluation and Research. INDs are required to conduct clinical trials in humans and transport a drug to trial sites, with applications ...
Drugs typically go through a twelve-step review process by the agency’s Center for Drug Evaluation and Research, with phases including animal testing, clinical trials, and facility inspections.
most notably Texas Children’s Hospital and The University of Texas MD Anderson Cancer Center. The CDD bridges the gap between academic research and pharmaceutical discovery and provides researchers ...
The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new small molecules, biologics and oligonucleotide therapeutics last year. The class of 2024 was a little smaller than that ...
As multisite clinical research corporations (MCRCs) proliferate to meet the increased demand for larger clinical trials that ...
The FDA urges manufacturers to revise labeling of transmucosal buprenorphine products to ease access to higher doses because ...