[ Price : $8.95]
A new journal article finds substantial differences in how major international regulators evaluate and approve oncology drugs that...[ Price : $8.95]
Former FDA commissioner Scott Gottlieb urges federal health officials to restore scientific leadership at the agency's medical pro...[ Price : $8.95]
Former FDA Office of New Drugs director Peter Stein criticizes the agency's National Priority Voucher program at the DIA Global An...[ Price : $8.95]
FDA posts a draft guidance outlining how sponsors can use quantitative systems pharmacology models to determine starting doses for...[ Price : $8.95]
FDA publishes a revised draft guidance that updates how sponsors can demonstrate "substantial evidence" of effectiveness for new d...[ Price : $8.95]
The agency releases a revised draft guidance aimed at helping sponsors design and conduct clinical trials using master protocols, ...[ Price : $8.95]
An opinion article calls on FDA to establish a formal regulatory framework for evaluating vaccines as potential interventions to p...[ Price : $8.95]
Merck says FDA has approved an expanded indication for its pneumococcal conjugate vaccine, Capvaxive, allowing its use in children...