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CGMP Violations at Koreas Hanlim Pharm

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FDA warns South Koreas Hanlim Pharma about CGMP violations in its manufacturing of finished pharmaceuticals.

Afrezza Facebook Post False, Misleading: OPDP

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CDERs Office of Prescription Drug Promotion says a Facebook post about MannKinds Afrezza misbrands the drug by failing to adequate...

2 Guidances to Help Modernize Clinical Trials

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As part of its continuing push to modernize clinical trials, FDA posts two guidance documents to provide greater clarity and recom...

PhRMA DTC Pricing Effort Aims to Stave Off Regulations

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Presumably to avert new FDA regulations about adding price information in direct-to-consumer ads, Pharmaceutical Research and Manu...

FDA Draft Guide on Rare Disease Pre-IND Meetings

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Federal Register notice: FDA makes available a draft guidance entitled Rare Diseases: Early Drug Development and the Role of Pre-I...

Class 1 Recall for Endologicx Endovascular AAA Device

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FDA classifies as a Class 1 recall an Endologix safety notice to healthcare professionals about its AFX Endovascular AAA [abdomina...

Civco Radiotherapy for Immobilization System

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FDA clears a Civco Radiotherapy 510(k) for its Solstice SRS Immobilization System.

Untitled Letter on Web Site Product Promotion

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CBER sends an untitled letter to the operator of two Web sites http://www.ollereg.com and http://www.innovativeallergy.com becau...

FDA Approves EyePoint Pharma Uveitis Drug

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FDA approves EyePoint Pharmaceuticals Yutiq (fluocinolone acetonide intravitreal implant) for treating chronic non-infectious uvei...

Guide on Revised Common Rule Implications

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FDA posts a guidance entitled Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.