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SCA Pharma Recalls Injectables Due to Contamination Concern

[ Price : $8.95]

SCA Pharmaceuticals recalls all lots of several injectable products because there is a potential for them to contain microbial con...

FDA Posts 51 Product-specifc Guidances for Generic Drugs

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FDA posts 51 product-specific guidances (32 new and 19 revised) describing the agencys current thinking and expectations on how to...

FDA Monitoring 50 Critical Devices Made in Puerto Rico

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FDA says it is paying equal attention to medical device manufacturers struggling alongside drug makers in Puerto Rico as they work...

FDA Extends Deadline for Lab Test Identifiers in Applications

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Federal Register notice: FDA announces an extension of the deadline to provide Logical Observation Identifiers Names and Codes for...

Class 2 for Microbial Pathogen Detectors In Cerebrospinal Fluid

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Federal Register notice: FDA classifies devices that detect and identify microbial pathogen nucleic acids in cerebrospinal fluid i...

Celgene Stops Studies in Crohns Disease

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Celgene discontinues its Phase 3 REVOLVE trial (CD-002) in Crohns disease and the extension trial (SUSTAIN, CD-004) that are both ...

Draft Guide on Generic Tiotropium Bromide Products

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Federal Register notice: FDA makes available a draft guidance for industry on generic tiotropium bromide inhalation powder.

3 Draft Guides on Generic Inhalation Drugs

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Federal Register notice: FDA makes available three draft guidances for industry on generic salmeterol xinafoate inhalation powder,...

Internal CDER Document on CMC Reviews

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FDA posts an internal policy and procedures document entitled CMC Reviews of Type III DMFs for Packaging Materials.

11 Observations on Atlas Pharmaceuticals FDA-483

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FDA issues an FDA-483 detailing 11 observations from an inspection at the Atlas Pharmaceuticals outsourcing facility.