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Stand Down on LDT Oversight Until Congress Acts: Attorney

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Attorney Jeffrey Shapiro calls on FDA to stop all enforcement oversight of laboratory-developed tests until Congress specifically ...

FDA and FTC Warn CBD Marketer

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FDA and FTC send a joint Warning Letter to Rooted Apothecary (Naples, Florida) for illegally selling unapproved products containin...

Vaccine Study Dataset Submission Guide

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FDA makes available a final guidance entitled Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review...

Final Guide Drug Manufacturing Establishment ID

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FDA posts a final guidance entitled Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Ques...

CGMP Violations at Jiangsu NHWA

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FDA warns Chinas Jiangsu NHWA Pharmaceuticals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

FDA Approves 1st Modified Risk Tobacco Products

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FDA approves eight smokeless tobacco products under the new modified risk tobacco product pathway.

IntelGenx Resubmits NDA for Migraine Drug

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FDA accepts for review an IntelGenx 505(b)(2) NDA resubmission for Rizaport VersaFilm (rizatriptan ) an oral disintegrating film f...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Jiangsu NHWA Pharmaceutical Co. and Sofie Co.

Concerns on FDA Gastroparesis Guidance

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Three stakeholders raise concerns with an FDA guidance on gastroparesis drug development.

FDA Breakthrough for Knee Biofilm Infection Killer

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FDA grants Garwood Medical a Breakthrough Device designation for its BioPrax device for eliminating biofilm infections on prosthet...