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Pharmaneek Inspection Form FDA-483 Out

[ Price : $8.95]

FDA releases the form FDA-483 with two observations from an inspection at the Pharmaneek non-sterile drug manufacturing facility i...

FDA Nixes Enforcement Action Against Whoop's Blood Pressure Feature

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FDA closes a potential enforcement action against Whoop Inc., reversing an earlier regulatory position that raised questions about...

Expand Real-World Evidence Use in Drug Approvals: Article

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Drug company executives recommend ways FDA could increase the use of real-world evidence in regulatory decisions.

Jubilant HollisterStier CGMP Issues

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FDA warns Canadas Jubilant HollisterStier General Partnership about CGMP violations in its manufacturing of finished drugs.

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...