[ Price : $8.95]
FDA issues a 26-page Form 483 to Alkem Laboratories following an 4/20-5/1 inspection of the company's finished drug manufacturing ...[ Price : $8.95]
FDA posts 17 revised draft product-specific guidances for peptide products, which it touts as a significant advancement in the age...[ Price : $8.95]
FDA encourages cancer clinical trial sponsors to adopt more flexible eligibility criteria related to washout periods and concomita...[ Price : $8.95]
A final FDA guidance urges sponsors of cancer clinical trials to broaden laboratory value-based eligibility criteria to reduce unn...[ Price : $8.95]
FDA announces an 8/6 educational Webinar to provide stakeholders with additional information about its proposed Expedited Investig...[ Price : $8.95]
Novo Nordisk intensifies pressure against Eli Lilly under a motion seeking a preliminary injunction to stop Eli Lilly's misleading...[ Price : $8.95]
CBER recently used a virtual town hall to urge developers of cell and gene therapies to take advantage of early engagements with t...[ Price : $8.95]
An FDA final guidance encourages sponsors of oncology clinical trials to broaden eligibility criteria by including more patients w...