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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...

Nicotine Dependence NDA Gets Complete Response Letter

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FDA sends Achieve Life Sciences a Complete Response Letter on its NDA for cytisinicline as a treatment for nicotine dependence.

Pharmaneek Inspection Form FDA-483 Out

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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.