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FDA Issues Early Alert on Abiomed Impella Introducer Kits

[ Price : $8.95]

FDA issues an early alert warning healthcare providers about a potentially high-risk device issue involving introducer kits used w...

FDA Bought Unapproved New Drugs on Amazon

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FDA warns Amazon it is marketing unapproved new drugs on its Web site.

Gottlieb Praises Clinical Trial Initiative; Calls for FDA Career Leadership

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Former FDA commissioner Scott Gottlieb supports the agency's newly announced initiative to accelerate early-stage clinical trials...

HHS Unveils Initiative to Accelerate U.S. Clinical Trials

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HHS unveils a broad, department-wide initiative aimed at speeding clinical research, reducing regulatory barriers, and attracting ...

Regenxbio Gets FDA Agreement to Refile Gene Therapy BLA

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Regenxbio reaches an agreement with FDA on a path toward a potential accelerated approval of Navsunli (clemidsogene lanparvovec-sn...

How Global Regulators Handle Cancer Drugs After FDA First Approval: Study

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A new journal article finds substantial differences in how major international regulators evaluate and approve oncology drugs that...

Ex-FDA Head Gottlieb Warns on Politicization Threatening Scientific Credibility

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Former FDA commissioner Scott Gottlieb urges federal health officials to restore scientific leadership at the agency's medical pro...

Former FDA Drug Chief Questions Future of Priority Voucher Program

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Former FDA Office of New Drugs director Peter Stein criticizes the agency's National Priority Voucher program at the DIA Global An...

Guide on Using Quantitative Systems Pharmacology Models for Trial Dosing

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FDA posts a draft guidance outlining how sponsors can use quantitative systems pharmacology models to determine starting doses for...

FDA Revises Guide on Demonstrating Drug Effectiveness

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FDA publishes a revised draft guidance that updates how sponsors can demonstrate "substantial evidence" of effectiveness for new d...