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Workshop on Dosing Pediatric Study Patients

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Federal Register notice: FDA announces an 11/30 public workshop entitled Advancing the Development of Pediatric Therapeutics (ADEP...

FDA Cut Corners to Approve Hetlioz ANDA: Vanda

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Vanda Pharmaceuticals asks the DC federal court to order FDA to vacate its corner-cutting approval of an MSN ANDA for a generic fo...

Upcoming CBER Changes Explained

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Attorney Maarika Kimbrell discusses the challenges facing CBER as it reorganizes to meet PDUFA 7 commitments and an increase in IN...

Ideaya Bio Gets Fast Track for IDE161

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FDA grants Ideaya Biosciences a Fast Track designation for IDE161 for treating certain adult patients having advanced or metastati...

Ionis Plans NDA for Triglyceride Drug

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Ionis Pharmaceuticals says it will file an NDA early next year after reporting Phase 3 topline results of olezarsen in people with...

Trax Compression Bone Screws Cleared

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FDA clears a Trax Surgical 510(k) to market its Trax Compression Screw System that offers a wide range of bone screws for osteotom...

Drug Use Software Guidance Analyzed by Attorneys

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Foley Hoag attorneys analyze the questions about promotional labeling raised by a recent FDA draft guidance on prescription drug u...

Novartis Touts Positive Lutathera Phase 3 Data

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Novartis says the Phase 3 NETTER-2 trial met its primary endpoint of improvement in progression-free survival and the key secondar...

FDA Reviewers Dismiss ALS Therapy Benefit

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FDA reviewers say clinical data submitted in a BrainStorm Cell Therapeutics BLA for Lou Gehrigs Disease treatment NurOwn do not de...

Calcipotriene ANDA Withdrawal Corrected

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Federal Register notice: FDA corrects a 6/2 notice wrongly announcing that Tomers ANDA for calcipotriene was being withdrawn.