[ Price : $8.95]
A Skadden Insights post raises the concern of FDA-regulated companies caused by the significant leadership changes at the agency.[ Price : $8.95]
FDA issues an early alert warning healthcare providers about a potentially high-risk device issue involving introducer kits used w...[ Price : $8.95]
FDA warns Amazon it is marketing unapproved new drugs on its Web site.[ Price : $8.95]
Former FDA commissioner Scott Gottlieb supports the agency's newly announced initiative to accelerate early-stage clinical trials...[ Price : $8.95]
HHS unveils a broad, department-wide initiative aimed at speeding clinical research, reducing regulatory barriers, and attracting ...[ 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FDA posts a draft guidance outlining how sponsors can use quantitative systems pharmacology models to determine starting doses for...[ Price : $8.95]
FDA publishes a revised draft guidance that updates how sponsors can demonstrate "substantial evidence" of effectiveness for new d...[ Price : $8.95]
The agency releases a revised draft guidance aimed at helping sponsors design and conduct clinical trials using master protocols, ...