[ Price : $8.95]
FDA posts a guidance outlining its intent to exempt several low-risk, unclassified medical devices from premarket notification req...[ Price : $8.95]
A Friends of Cancer Research white paper recommends three ways the FDA Biomarker Qualification Program could be improved.[ Price : $8.95]
U.S. House lawmakers introduce bipartisan legislation aimed at expanding federal scrutiny of U.S. investments in China's biotechno...[ Price : $8.95]
Former FDAers Richard Pazdur and Nicole Gormley promote ways to restructure the agency so it can be more independent and successfu...[ Price : $8.95]
FDA has accepted a Letter of Intent for the first in silico artificial intelligence-driven digital liver model for predicting drug...[ Price : $8.95]
FDA accepts for priority review a Roche NDA for giredestrant, an investigational oral endocrine therapy for patients with early-st...[ Price : $8.95]
FDA issues an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease therapy Sucraid (sacrosidase) ...[ Price : $8.95]
FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aerosol after the company failed ...