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FDA Breakthrough Status for Tevas SD-809

[ Price : $8.95]

FDA grants Teva Pharmaceutical Industries a breakthrough therapy designation for SD-809 (deutetrabenazine) for treating patients w...

FDA Grants Collegium Tentative Approval on Pain Drug

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FDA grants Collegium Pharmaceutical tentative approval for its NDA for Xtampza ER (oxycodone) extended-release capsules for managi...

Purdue Petition Seeking Delay on Pfizer Pain Drug Denied

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FDA denies without comment a petition from Purdue Pharma that sought an order from FDA to require a Pfizer 505(b)(2) NDA for pain ...

Ex-FDA Chief of Staff Joins DC Law Firm

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Former FDA chief of staff and deputy chief counsel Denise Esposito joins Covington & Burling as a partner and co-chair of its food...

China API Inspection Passes with No 483 Citations

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FDA inspects a ScinoPharm drug manufacturing facility located in the Changshu Economic Development Zone in Jiangsu Province, China...

FDA Clears EDAP Ablatherm HIFU for Prostate Tissue

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FDA clears an EDAP TMS 510(k) to market its Ablatherm Integrated Imaging HIFU (High intensity focused ultrasound) for ablating pro...

CDER Policy on ANDA Amendment Filing Reviews

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CDER posts a policy document on the Review of ANDA Amendments and Supplements by the Division of Filing Review.

FDA Rare Pediatric Disease Status for ArmaGen Drug

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FDA grants ArmaGen a rare pediatric disease designation for AGT-181, a potential treatment for patients with Hurler syndrome.

Amgen NDA for Etelcalcetide Accepted for Review

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FDA accepts for review an Amgen NDA for etelcalcetide (formerly AMG 416) for treating secondary hyperparathyroidism in patients wi...

FDA Panel Recommends Stricter Labeling for Fluoroquinolones

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FDAs Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommend a revised indicat...