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EIRS/483s

Federal Register notice: FDA classifies prognostic tests for assessing liver-related disease progres...

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EIRS/483s

Hyman Phelps & McNamara attorneys Mark Tobolowsky and Charles Raver say a recent legislative change ...

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EIRS/483s

FDA commissioner Robert Califf calls for better evidence generation and suggests that with the rapid...

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EIRS/483s

Lawyers from Troutman Pepper say that two recent medical product cases could be a harbinger of more ...

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EIRS/483s

FDA approves an IntelGenx 505(b)(2) NDA for RizaFilm VersaFilm (rizatriptan benzoate) for treating a...

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EIRS/483s

Industry news you may have missed since our last issue.

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EIRS/483s

FDA-483 issued 10/23/97

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EIRS/483s

Company response dated 7/14/98

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EIRS/483s

Warning Letter dated 6/25/98

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EIRS/483s

Lyons, IL facility inspected 11/16-22/99; FDA Form 483; Warning Letter 1/5/00 and company response

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EIRS/483s

Wilmington, CA facility inspected 1/10,13-14/00; FDA Form 483

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EIRS/483s

Teachey, NC facility inspected 4/12-4/15/99; FDA 48 4/15/99, Warning Letter 8/2/99

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EIRS/483s

Haw River, NC facility inspected 4/19-29/99; FDA 483, Warning Letter 6/28/99

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EIRS/483s

FDA-483 issued 3/98 to Buena, NJ facility

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EIRS/483s

FDA-483 issued 10/98 to Buena, NJ facility

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EIRS/483s

FDA-483 issued 4/98 to Buena, NJ facility

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EIRS/483s

Company response dated 4/14/98 to 2-3/98 inspection

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EIRS/483s

Company response dated 5/22/98 to FDA Warning Letter

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EIRS/483s

Company response dated 5/4/98 to 3-4/98 inspection at Buena, NJ facility

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EIRS/483s

Burr Ridge, IL facility inspected 1/19-28/99; FDA Form 483.