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Arena Gains Fast Track for Heart Failure Drug

[ Price : $8.95]

FDA grants Arena Pharmaceuticals a fast track designation for APD418, a β3-adrenergic receptor antagonist and cardiac myotrop...

FDA Denies Otsuka Samsca Petition

[ Price : $8.95]

FDA denies an Otsuka petition asking that it determine that the companys Samsca was withdrawn for reasons of safety and that no ge...

10 Drug Promo Violation Letters in 2019

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Eye on FDA says the CDER Office of Prescription Drug Promotion issued 10 enforcement letters in 2019 with 21 violations in 11 comm...

ResMed Pays $37.5 Million Over False Claims

[ Price : $8.95]

ResMed Corp. (San Diego, CA) agrees to pay more than $37.5 million to resolve alleged False Claims Act violations for paying kickb...

Dont Use Certain Level 3 Surgical Gowns: Cardinal Health

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CDRH director Jeffrey Shuren says customers should follow a Cardinal Health recommendation not to use lots of Level 3 surgical gow...

FDA Publishes Right to Try Information

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FDA posts information about the 2018 Right to Try law and how certain patients may be able to access unapproved drugs and biologic...

Oncology Pediatric Study Plans Guide

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Federal Register notice: FDA makes available a draft guidance entitled Pediatric Study Plans for Oncology Drugs: Questions and Ans...

Device PMA Advisory Meetings Disappearing: Attorneys

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Attorneys Jeffrey Gibbs and McKenzie Cato say that FDA advisory committee meetings to review product applications may become a thi...

Clovis sNDA for Rubraca Accepted for Review

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FDA accepts for priority review a Clovis Oncology supplemental NDA for Rubraca (rucaparib) and its use as monotherapy treatment in...

Neovasc PMA for Reducer Accepted for Review

[ Price : $8.95]

FDA accepts for review a Neovasc PMA for its Neovasc Reducer for treating refractory angina.