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FDA Debars Kulakevich for 5 Years

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Federal Register notice: FDA issues an order debarring William Kulakevich for five years from importing or offering for import any...

Objectionable Conditions at Ukraine Clinical Test Site

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FDA warns a clinical trial site in Ukraine that it failed to properly maintain required records.

Aspen Institute Cell Products Illegal: FDA

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FDA cautions Aspen Institute that it is illegally marketing cellular and exosome products to treat diseases and conditions in huma...

Location Affects FDA Device Inspections: Analysis

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Epstein, Becker & Green attorney Bradley Thompson says there are differences between counties in the numbers of medical device ins...

Senate Committee Vote on Califf Nomination Delayed

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The Senate Health, Education, Labor & Pensions Committee delays a 1/5-scheduled confirmation vote on FDA commissioner nominee Robe...

FDA Contributed to Covid Test Shortage: Lawyers

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Attorneys Jeffrey Gibbs and Gail Javitt say FDA contributed to the shortage of Covid-19 tests and call for a thorough, objective r...

FDA Wants iPLEDGE Web Site Solutions

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FDA calls on isotretinoin manufacturers to propose a workable solution to issues with the iPLEDGE REMS Web site and telephone call...

Amcyte Pharma Marketing Illegal Covid Drug: FDA

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FDA warns Kirkland, WA-based Amcyte Pharma it is illegally selling Nasitrol, an unapproved and misbranded drug, as a Covid-19 cure...

Abbvie Gets Breakthrough Status on Lung Cancer Drug

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FDA grants AbbVie a breakthrough therapy designation for telisotuzumab vedotin and its use in treating certain patients with advan...

Novavax to Seek Covid Vaccine EUA

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Novavax expects to apply this month for an FDA EUA for its Covid-19 two-dose vaccine.