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Comments Sought on Sunscreen Info Collection

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Sun Protection Factor Labeling and Tes...

Draft Guide on Osteoarthritis Structural Endpoints

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Federal Register notice: FDA makes available a draft guidance entitled Osteoarthritis: Structural Endpoints for the Development of...

Members Sought for Device Advisory Panels

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Federal Register notice: FDA requests nominations for voting members to serve on the Device Good Manufacturing Practice Advisory C...

Danicrine Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Danocrine (danazol) Capsules, 50mg, 100mg, and 200mg, were not withdrawn from sale fo...

Class 1 Recall of bioMerieux Vitek 2 Test Cards

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FDA classifies as Class 1 a bioMerieux recall of its Vitek 2 Gram Positive Antimicrobial Susceptibility Testing Cards due to false...

Biocodex Seizure Drug Approved by FDA

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FDA approves a Biocodex SAS NDA for Diacomit (stiripentol) for treating seizures associated with Dravet syndrome in patients two y...

FDA Approves Roches Test for Iressa

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FDA approves Roches cobas EGFR Mutation Test v2 as a companion diagnostic test for selecting patients suitable for AstraZenecas Ir...

FDA Approves Kala Eye Pain Drug

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FDA approves a Kala Pharmaceuticals NDA for Inveltys (loteprednol etabonate ophthalmic suspension) 1% for treating post-operative ...

Osteoarthritis Product Development Guidance

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FDA publishes a draft osteoarthritis medical product development guidance.

FDA Funding Opioid Prescribing Study

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FDA contracts with the National Academies to advance development of opioid prescribing evidence-based guidelines.