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Par Pharmaceutical Recalls 1 Treprostinil Lot

[ Price : $8.95]

Par Pharmaceutical recalls one lot of treprostinil injection due to the potential for the presence of silicone particulates in the...

Drug Supply Small Dispenser Info Collection

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Federal Register notice: FDA seeks comments on a new proposed information collection entitled Proposed Small Dispensers Assessment...

Nonprescription Drug Labeling Changes Draft Guide

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Federal Register notice: FDA makes available a draft guidance entitled Annual Reportable Labeling Changes for NDAs and ANDAs for N...

Draft Guide on Device Cybersecurity

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Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Premarket Cybersecurity Guidance: Se...

Pharmaceutical Science Advisory Panel Renewed

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Federal Register notice: FDA renews its Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional two ...

Help Industry with Bad Labs: Post

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A Hyman, Phelps & McNamara medical device regulatory expert and attorney say FDA should help industry learn how to avoid labs that...

QS, MDR Issues Seen in Exactech Inspection

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FDA warns Gainesville, FL-based Exactech about Quality System and Medical Device Report violations in its manufacturing of orthope...

Minor Drug Labeling Change Reporting Guide

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FDA publishes a draft guidance with recommendations for NDA and ANDA applicants for nonprescription drugs to document minor labeli...

False or Misleading Senvelgo Claims: CVM

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CVM warns Boehringer Ingelheim Animal Health USA that promotional communications for its Senvelgo make false and misleading claims...

Cybersecurity Guidance Updates Proposed

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FDA publishes a draft guidance proposing select updates to its existing premarket cybersecurity guidance.