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4 CGMP Violations in Huons Inspection

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FDA warns South Koreas Huons Co. about CGMP violations in its manufacturing of finished drugs.

FDA Leadership Upheaval Yields Uncertainty: Post

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A Skadden Insights post raises the concern of FDA-regulated companies caused by the significant leadership changes at the agency.

FDA Issues Early Alert on Abiomed Impella Introducer Kits

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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...

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...

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 ...