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Joint Advisory Panel to Review Irritable Bowel Drug

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Federal Register notice: FDA announces a 10/17 joint advisory committee meeting to review an irritable bowel syndrome drug.

CGMP Violations Found in Lernapharm Inspection

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FDA warns Canadas Lernapharm about CGMP violations in its production of finished drugs.

Comments on Draft Indications and Usage Labeling Guidance

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Four pharmaceutical stakeholders submit comments on an FDA draft guidance on writing the Indications and Usage section in product ...

Procedural Deficiency in Lupin Tarapur Inspection

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Indias Lupin says an FDA inspection at its Tarapur drug manufacturing facility closed with one observation the company considers t...

CGMP Violations at Chinas Longwood Medicine (Beijing)

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FDA warns Chinas Longwood Medicine (Beijing) about CGMP violations in its production of an unapproved new drug.

Guide on Drug Substance Postapproval Changes

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Federal Register notice: FDA makes available a draft guidance entitled Postapproval Changes to Drug Substances.

Info Collection on Biosimilar Formal Meetings

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Federal Register notice: FDA submits to OMB an information collection extension Guidance for Industry: Formal Meetings between the...

Ex-FDA Top Lawyer Returns to Sidley Austin

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Former FDA chief counsel Rebecca Wood rejoins Sidley Austin to co-lead both the firms food, drug and medical device regulatory pra...

Cook Medical Gets Warning Letter Close-out

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Cook Medical gets an FDA close-out letter resolving a 2014 Warning Letter for processes related to the companys quality system at ...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Lernapharm (Loris), Longood Medicine and two letters to Medtronic.