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 ...
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 rate of warnings initiated by the FDA continues to rise in the pharma and medical device industries. Knowing how to best ...
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 ...
and Critical Care in the FDA’s Center for Drug Evaluation and Research, per the press release. “This is a major step forward for patients with obstructive sleep apnea.” The FDA conducted two ...
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...
The FDA urges manufacturers to revise labeling of transmucosal buprenorphine products to ease access to higher doses because ...