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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FDA posts a draft guidance outlining how sponsors can use quantitative systems pharmacology models to determine starting doses for...[ Price : $8.95]
FDA publishes a revised draft guidance that updates how sponsors can demonstrate "substantial evidence" of effectiveness for new d...[ Price : $8.95]
The agency releases a revised draft guidance aimed at helping sponsors design and conduct clinical trials using master protocols, ...[ Price : $8.95]
Regenxbio reaches an agreement with FDA on a path toward a potential accelerated approval of Navsunli (clemidsogene lanparvovec-sn...