The Pharmaceutical Research and Manufacturers of America urges FDA to revise and clarify its draft guidance on using quantitative systems pharmacology...
FDA issues a 26-page Form 483 to Alkem Laboratories following an 4/20-5/1 inspection of the company's finished drug manufacturing facility in Daman, I...
FDA posts 17 revised draft product-specific guidances for peptide products, which it touts as a significant advancement in the agencys scientific and ...
FDA encourages cancer clinical trial sponsors to adopt more flexible eligibility criteria related to washout periods and concomitant medications.
A final FDA guidance urges sponsors of cancer clinical trials to broaden laboratory value-based eligibility criteria to reduce unnecessary barriers to...
FDA announces an 8/6 educational Webinar to provide stakeholders with additional information about its proposed Expedited Investigational New Drug Pil...
Novo Nordisk intensifies pressure against Eli Lilly under a motion seeking a preliminary injunction to stop Eli Lilly's misleading GLP-1 advertising c...
CBER recently used a virtual town hall to urge developers of cell and gene therapies to take advantage of early engagements with the agency well befor...
