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Jiangsu Hengrui Inspection Nets 8-item 483

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A January FDA inspection at Jiangsu Hengrui Pharmaceuticals in Jiangsu, China, leads to an eight-observation Form FDA-483 that cit...

23 No-Longer-Marketed NDAs Withdrawn

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Federal Register notice: FDA withdraws 23 NDAs from multiple applicants after being notified by the application holders that the p...

Info Collection on Device Recall Authority

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Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Device Recall Authority 21 CF...

FDA Promoting Pragmatic Clinical Research: Califf

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FDA commissioner Robert Califf and two colleagues make the case for so-called pragmatic clinical research using real-world evidenc...

BMS Reports Positive Opdivo plus Yervoy Data

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Bristol Myers Squibb reports favorable data from a Phase 3 trial evaluating the dual immunotherapy combination of Opdivo (nivoluma...

Multiple QS Issues in Techlem Inspection

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FDA warns Mississauga, Canada-based Techlem Medical Corporation about Quality System violations in its manufacture of misbranded w...

Arrow Recalls FiberOptix Intra-Aortic Catheter

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Arrow International recalls (Class 1) its Arrow FiberOptix Intra-Aortic Balloon Catheter Kit after receiving reports about infrequ...

3 Comments on BA/BE Data Integrity Guidance

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Three stakeholders give technical suggestions to change an FDA draft guidance on data integrity for in vivo bioavailability and bi...

Little Debarred Over Unapproved Drugs

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Federal Register notice: FDA issues an order debarring Michael Terry Little for five years from importing or offering for import a...

Agios Filing NDA on Thalassemia Drug

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Agios Pharmaceuticals plans to submit by the end of the year an NDA for mitapivat and its use on adults with transfusion-dependent...